Randomized trial of volume expansion with albumin or saline in children with severe malaria: preliminary evidence of albumin benefit. Albumin supplementation in the critically ill. A prospective, randomized trial. Albumin administration improves organ function in critically ill hypoalbuminemic patients: A prospective, randomized, controlled, pilot study. Volume expansion with albumin compared to gelofusine in children with severe malaria: results of a controlled trial. [Effect of hydroxyethyl starch HES 450/0.7 and 5% human albumin on the colloid osmotic pressure and hemodynamic parameters in hypovolemic patients after major abdominal procedures]. Therapeutic influence of 20 % albumin versus 6% hydroxyethylstarch on extravascular lung water in septic patients: a randomized controlled trial. Maintenance of serum albumin levels in pediatric burn patients: a prospective, randomized trial. A prospective analysis of hypertonic lactated saline v. Ringer's lactate-colloid for the resuscitation of severely burned children. Efficacy of albumin supplementation in the surgical intensive care unit: a prospective, randomized study. Short-term effectiveness of different volume replacement therapies in postoperative hypovolaemic patients. Randomized trial of normal saline versus 5% albumin for the treatment of neonatal hypotension. Randomised controlled trial of albumin infusion in ill preterm infants. Postoperative albumin infusion therapy based on colloid osmotic pressure. A prospectively randomized trial. Volume therapy in the critically ill: is there a difference? A prospective randomized trial evaluating colloid versus crystalloid resuscitation in the treatment of the vascular leak syndrome associated with interleukin-2 therapy. A triple-blinded randomized trial comparing the hemostatic effects of large-dose 10% hydroxyethyl starch 264/0.45 versus 5% albumin during major reconstructive surgery. Randomized, double-blind study of intravenous human albumin in hypoalbuminemic patients receiving total parenteral nutrition. Rapid infusion of sodium bicarbonate and albumin into high-risk premature infants soon after birth: a controlled, prospective trial. Randomised controlled trial of colloid or crystalloid in hypotensive preterm infants. A randomized unblinded pilot study comparing albumin versus hydroxyethyl starch in spontaneous bacterial peritonitis. Hypoalbuminemia is a poor predictor of survival after percutaneous endoscopic gastrostomy in elderly patients with dementia. Randomized comparative multicenter study of hydroxyethyl starch versus albumin as a plasma expander in cirrhotic patients with tense ascites treated with paracentesis. Colloid solutions in the critically ill. A randomised comparison of albumin and polygeline. 1. Outcome and duration of stay in the intensive care unit. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. Comparison of the hemodynamic and oxygen transport responses to modified fluid gelatin and hetastarch in critically ill patients: a prospective, randomized trial. Effect of albumin supplementation during parenteral nutrition on hospital morbidity. Effects of polygeline and hydroxyethyl starch solutions on liver functions assessed with LIMON in hypovolemic patients. Custom-tailored hemodilution with albumin and crystalloids in acute ischemic stroke. [Comparison of postoperative volume therapy in heart surgery patients]. Fluid resuscitation with Haemaccel vs. human albumin following coronary artery bypass grafting. HES 130/0.4 (Voluven) or human albumin in children younger than 2 yr undergoing non-cardiac surgery. A prospective, randomized, open label, multicentre trial. [Comparative study of the intraoperative effectiveness of 5% human albumin or 10% hydroxyethyl starch (HAES-steril) on hemodynamics and oxygen transport in 40 patients]. Intravenous albumin for the prevention of severe ovarian hyperstimulation syndrome in an in vitro fertilization program: a prospective, randomized, placebo-controlled study. Intravenous albumin versus hydroxyethyl starch for the prevention of ovarian hyperstimulation in an in-vitro fertilization programme: a prospective randomized placebo controlled study. Hemodynamic effects of 6% and 10% hydroxyethyl starch solutions versus 4% albumin solution in septic patients. Albumin dialysis in cirrhosis with superimposed acute liver injury: a prospective, controlled study. Concurrent administration of albumin with total parenteral nutrition in sick newborn infants. Five percent albumin for adult burn shock resuscitation: lack of effect on daily multiple organ dysfunction score. The value of an albumin-based intravascular volume replacement strategy in elderly patients undergoing major abdominal surgery. Albumin influences total plasma antioxidant capacity favorably in patients with acute lung injury. Replacement of major surgical blood loss by hypo-oncotic or conventional plasma substitutes.
Metabolic acidosis is the best predictor of death in children with severe falciparum malaria; however, its treatment presents a therapeutic dilemma, because acidosis and hypovolemia may coexist with coma, which can be associated with elevated intracranial pressure. We postulated that volume resuscitation with albumin might correct acidosis and hypovolemia with a lower risk of precipitating cerebral edema than crystalloid. In an open-label, randomized, controlled trial, we compared the safety of resuscitation with albumin to saline in Kenyan children with severe malaria.
                We randomly assigned children with severe malaria and metabolic acidosis (base deficit, >8 mmol/L) to receive fluid resuscitation with either 4.5% albumin or normal saline. A control (maintenance only) group was only included for patients with a base deficit of <15 mmol/L. The primary outcome measure was the percentage reduction in base deficit at 8 h. Secondary end points included death, the requirement for rescue therapies, and neurological sequelae in survivors.
                Of 150 children recruited for the trial, 61 received saline, 56 received albumin, and 33 served as control subjects. There was no significant difference in the resolution of acidosis between the groups; however, the mortality rate was significantly lower among patients who received albumin (3.6% [2 of 56 patients]) than among those who received saline (18% [11 of 61]; relative risk, 5.5; 95% confidence interval, 1.2-24.8; P=.013).
                In high-risk children with severe malaria and acidosis, fluid resuscitation with albumin may reduce mortality. Our study design did not enable us to determine whether saline administration is preferable to fluid restriction or whether saline administration is actually hazardous. Further studies are needed to confirm our findings before definitive treatment recommendations can be made. Albumin replacement to correct hypoalbuminemia in critically ill patients has been controversial. This study was a prospective, randomized trial of 25% albumin administration in 40 hypoalbuminemic (serum albumin, less than 25 g/L [2.5 g/dL]), critically ill patients. The treatment group (18 patients) received 25% albumin supplementation to achieve and maintain serum albumin levels of 25 g/L (2.5 g/dL) or greater, while the nontreatment group (22 patients) received no concentrated albumin. There was no clinical benefit from albumin therapy when assessing mortality (39% vs 27%, treatment vs control) or major complication rate (89% vs 77% of patients). There were also no significant differences in length of hospital stay, intensive care unit stay, ventilator dependence, or tolerance of enteral feeding, despite significant elevations of albumin in the treatment group. The costly use of exogenous albumin as treatment for hypoalbuminemia in this patient population does not appear to be justified. To test the hypothesis that administration of albumin to correct hypoalbuminemia might have beneficial effects on organ function in a mixed population of critically ill patients.
                : Prospective, controlled, randomized study.
                Thirty-one-bed, mixed medicosurgical department of intensive care.
                All adult patients with a serum albumin concentration < or =30 g/L were assessed for eligibility. Principal exclusion criteria were expected length of stay <72 hrs, life expectancy <3 months or a do-not-resuscitate order, albumin administration in the preceding 24 hrs, or evidence of fluid overload.
                The 100 patients were randomized to receive 300 mL of 20% albumin solution on the first day, then 200 mL/day provided their serum albumin concentration was <31 g/dL (albumin group), or to receive no albumin (control group).
                The primary outcome was the effect of albumin administration on organ function as assessed by a delta Sequential Organ Failure Assessment score from day 1 to day 7 (or the day of intensive care discharge or death, whichever came first). The two groups of 50 patients were comparable at baseline for age, gender, albumin concentration, and Acute Physiology and Chronic Health Evaluation II score. Albumin concentration did not change over time in the control group but increased consistently in the albumin group (p < .001). Organ function improved more in the albumin than in the control group (p = .026), mainly due to a difference in respiratory, cardiovascular, and central nervous system components of the Sequential Organ Failure Assessment score. Diuretic use was identical in both groups, but mean fluid gain was almost three times higher in the control group (1679 +/- 1156 vs. 658 +/- 1101 mL, p = .04). Median daily calorie intake was higher in the albumin than in the control group (1122 [935-1158] vs. 760 [571-1077] kcal, p = .05).
                Albumin administration may improve organ function in hypoalbuminemic critically ill patients. It results in a less positive fluid balance and a better tolerance to enteral feeding. Previous studies have shown that in children with severe malaria, resuscitation with albumin infusion results in a lower mortality than resuscitation with saline infusion. Whether the apparent benefit of albumin is due solely to its colloidal properties, and thus might also be achieved with other synthetic colloids, or due to the many other unique physiological properties of albumin is unknown. As albumin is costly and not readily available in Africa, examination of more affordable colloids is warranted. In order to inform the design of definitive phase III trials we compared volume expansion with Gelofusine (succinylated modified fluid gelatin 4% intravenous infusion) with albumin.
                This study was a phase II safety and efficacy study.
                The study was conducted at Kilifi District Hospital, Kenya.
                The participants were children admitted with severe falciparum malaria (impaired consciousness or deep breathing), metabolic acidosis (base deficit > 8 mmol/l), and clinical features of shock.
                The interventions were volume resuscitation with either 4.5% human albumin solution or Gelofusine.
                Primary endpoints were the resolution of shock and acidosis; secondary endpoints were in-hospital mortality and adverse events including neurological sequelae.
                A total of 88 children were enrolled: 44 received Gelofusine and 44 received albumin. There was no significant difference in the resolution of shock or acidosis between the groups. Whilst no participant developed pulmonary oedema or fluid overload, fatal neurological events were more common in the group receiving gelatin-based intervention fluids. Mortality was lower in patients receiving albumin (1/44; 2.3%) than in those treated with Gelofusine (7/44; 16%) by intention to treat (Fisher's exact test, p = 0.06), or 1/40 (2.5%) and 4/40 (10%), respectively, for those treated per protocol (p = 0.36). Meta-analysis of published trials to provide a summary estimate of the effect of albumin on mortality showed a pooled relative risk of death with albumin administration of 0.19 (95% confidence interval 0.06-0.59; p = 0.004 compared to other fluid boluses).
                In children with severe malaria, we have shown a consistent survival benefit of receiving albumin infusion compared to other resuscitation fluids, despite comparable effects on the resolution of acidosis and shock. The lack of similar mortality benefit from Gelofusine suggests that the mechanism may involve a specific neuroprotective effect of albumin, rather than solely the effect of the administered colloid. Further exploration of the benefits of albumin is warranted in larger clinical trials. In a randomized study 20 patients with hypovolemia following abdominal surgery for malignoma were treated with 500 ml HES 450/0.7 or human albumin 5% during the first 24 h after operation. COP and various blood- and hemodynamic parameters were measured immediately before and after infusion as well as 2, 4 and 6 h after infusion. After HES-infusion COP increased from 20.2 to about 22 mmHg and remained at a significantly higher level (p less than 0.01) for 6 h. After albumin-infusion COP increased from 19.7 to 20.7 mmHg, but already returned to starting level within 2 h. CVP in the HES-group increased from 2.8 to 6.3 cmH2O after infusion, and then gradually dropped to 4 cmH2O during 6 h. In the albumin-group CVP increased from the same starting level only to 4.2 cmH2O, and then dropped back to 3.2 cmH2O after 6 h (no significant difference to the starting level). The other blood- and hemodynamic parameters measured showed no significant differences between the two groups. The results show that a quick and reliable improvement of hypovolemia can be obtained in both groups immediately after infusion, but that the COP- and volume-stabilizing effects of HES-infusion are more distinct and remained for a significantly longer period of time than the effects of albumin 5%-infusion. Recent studies demonstrated that extravascular lung water (EVLW) is a reliable and independent marker for outcome. The primary therapeutically goal in critically ill patients is to resuscitate and retain adequate organ perfusion by fluid administration, where is necessary to achieve adequate intravascular filling, but avoid initiation of pulmonary edema.
                Patients with severe sepsis were randomly allocated to a group treated with 20% Albumin 100 ml every 12 hours (ALB; n = 30) or with 6% hydroxyethylstarch 130/0, 4 250 ml every 6 hours (HES; n = 26). Both treatments were completed by crystalloids or norephinephrin as necessary. We analyzed amount of developed EVLW, and relation with mortality, PaO2/FiO2 and alveolo-arterial oxygen difference.
                We observed significantly greater decrease of EVLW when compared with baseline during whole monitored period of 72 hours in ALB group in contrast to HES patients (p < 0.05). Despite no significant changes of EVLW in HES group, we noted improve of PaO2/FiO2 and AaDO2 in both groups. We did not observed significant difference in mortality.
                The present study results show can summarize that albumin reduces in a higher amount and earlier the extravascular lung water than HES, but this reduction was not associated with improvement of oxygenation functions, which was better in HES group. A prospective, randomized trial was performed to determine whether maintaining serum albumin levels in burned pediatric patients had any effect on morbidity and mortality. Patients < 19 years of age with burns > 20% total body surface area were randomized to receive supplemental albumin to maintain levels 2.5 to 3.5 g/dL ("High Albumin") or were given albumin only if levels dropped < 1.5 g/dL ("Low Albumin") after completing burn shock resuscitation. The 36 patients in the Low Albumin group were well matched for age, burn size, depth of injury, and inhalation injury when compared with the High Albumin group (34 patients). As expected, serum albumin levels were significantly lower in the Low Albumin group when compared with the High Albumin group. No differences between groups were noted for resuscitation needs, maintenance fluid requirements, urine output, tube feedings received, days of antibiotic treatment, or ventilatory requirements. No differences in hematology, electrolytes, or nutritional laboratories were found. Finally, length of stay, complication rate, and mortality were not affected by albumin treatment. Albumin supplementation to maintain normal serum levels does not seem to be warranted in previously healthy children who suffer severe burns and who receive adequate nutrition. Children and young people ranging in age from 5 months to 21 years, with burns covering greater than or equal to 30 per cent of the body surface area, were entered into a prospective study comparing the resuscitative efficacy of hypertonic lactated saline (HLS) and Ringer's lactate-colloid (RL-colloid). The 24- and 48-h fluid requirements of children resuscitated with the RL-colloid were significantly greater than those resuscitated with HLS (P less than 0.02); 2.37 +/- 0.91 ml/kg/per cent burn (HLS) v. 3.43 +/- 1.51 ml/kg/per cent burn (RL-colloid) at 24 h post-burn and 4.18 +/- 1.37 ml/kg/per cent burn (HLS) v. 6.32 +/- ml/kg/per cent burn (RL-colloid) at 48 h (P less than 0.01). The urine output between the two groups was not significantly different, and the haematocrits were equally maintained. Patients in the RL-colloid group gained significantly more weight at 48 h (P less than 0.05). The sodium requirements and resulting sodium balances were not significantly different. The desired and significant elevation (P less than 0.001) of serum sodium in the HLS group was maintained for the 5 days of the study. Colloid oncotic pressures, serum albumin and albumin/globulin (A/G) ratios were not significantly different between the two groups until 48 h post-burn. The RL-colloid group received plasmanate during the second 24-h period. The significant elevation in serum albumin, A/G ratio and colloid oncotic pressure persisted for only 2 days--by 96 h post-burn these values were no longer significantly different.(ABSTRACT TRUNCATED AT 250 WORDS) To determine the efficacy of supplemental 25% albumin in reducing morbidity and mortality rates in the surgical intensive care unit (ICU).
                Prospective, randomized, unblinded clinical study.
                Surgical ICU in a community hospital.
                Two hundred nineteen patients with admission circulating albumin concentrations of < 3.0 g/dL (< 30 g/L). The groups were well matched regarding age, sex, Acute Physiology and Chronic Health Evaluation II scores and initial circulating albumin concentrations.
                The treatment group (n = 116) received 37.5 g/day of albumin until the circulating albumin concentration increased to > 3.0 g/dL (> 30 g/L). The control group (n = 103) received no supplemental albumin. Both groups received standard nutritional support.
                The complication rate was 44% in the albumin group vs. 36.9% in the controls (p = .29). The albumin patients had a mortality rate of 10.3% vs. 5.8% in the control group (p = .22). There were no significant differences between the groups in the number of days spent receiving mechanical ventilation or in the tolerance to tube feedings.
                Routine supplemental administration of 25% albumin is expensive and offers no apparent outcome advantage and should be abandoned in the treatment of patients in the surgical ICU. To examine the kinetics of volume loading with crystalloid and colloid infusions in critically ill patients after major surgery, using the pulse contour cardiac output (PiCCO) monitoring technique.
                This prospective, randomized, multicentre study of 11 ICUs involved 200 mixed postoperative hypovolaemic patients (50 patients per group) in Hungary. Patients received 10 ml kg of lactated Ringer's solution, succinylated gelatin 4% w/v, 130/0.4 hydroxyethyl starch 6% w/v (HES) or human albumin 5% w/v over 30 min. A complete haemodynamic profile was obtained at 30, 45, 60, 90 and 120 min after baseline. The peak haemodynamic effects, the 120 min changes compared with baseline, the area under the curve (AUC) for the haemodynamic parameters over 120 min and the haemodilution effect of the solutions were analysed. The primary outcome was to compare the AUCs and the secondary outcome was to evaluate the haemodynamic changes at 120 min.
                There were significant differences in the AUCs of the haemodynamic parameters between colloids and lactated Ringer's solution in the cardiac index and global end-diastolic volume index (GEDVI); human albumin vs. lactated Ringer's solution in stroke volume variation (SVV); and succinylated gelatin, HES vs. lactated Ringer's solution in the oxygen delivery index (DO2I). Colloid infusions (mainly HES and human albumin) at 120 min caused significant changes in central venous pressure, cardiac index, GEDVI, SVV, DO2I and central venous oxygen saturation compared with baseline. The haemodilution effect was significantly greater in colloids vs. lactated Ringer's solution.
                In postoperative hypovolaemic patients, lactated Ringer's solution can significantly improve haemodynamics at the end of volume loading, but this effect completely disappears at 120 min. Ten millilitres per kilogram of colloid bolus (especially HES) improved the haemodynamics at 120 min; however, this was by only 5-25% compared with baseline. The colloids caused significantly larger AUCs than lactated Ringer's solution, but only in the cardiac index, GEDVI and DO2I, plus human albumin in the SVV. This study was designed to assess the comparative efficacy of normal saline (NS) and 5% albumin (ALB) for treatment of hypotension in the acutely ill newborn.
                Newborn infants who were < 24 hours old and were admitted to the Holden Neonatal Intensive Care Unit at the University of Michigan were randomized to receive one of the two solutions for volume expansion. Hypotension was defined as a sustained (> or =30 minutes) mean arterial pressure (MAP) of < 30 mmHg for infants weighing < or =2500 g, or a MAP of < 40 mmHg for those weighing > 2500 g. The short-term outcome measure was the resolution of hypotension defined as a MAP over the minimum limits set for birthweight sustained for > or =30 minutes.
                In total 41 infants met criteria and were entered. Of these, 21 infants received ALB and 20 received NS. Successful treatment was seen in 17/21 (81%) of infants in the ALB group and 17/20 (85%) of infants in the NS group. There was no statistically significant difference in response to treatment (p=0.30). In addition, there was no statistically significant difference in the magnitude of change in MAP between the two (p=0.41).
                NS was shown to be as effective as ALB for the correction of acute hypotension in the newborn infant. Given comparable efficacy of NS, along with its relatively low cost and availability, it should be considered the initial treatment of choice in this setting. We assessed the effect of albumin infusion on weight loss and ventilation requirement in sick premature infants. Thirty infants, median gestational age 29 weeks, were entered into a randomised controlled trial, at a median of 2 days of age. The infants, all with an albumin level < or = 30 g/l, received either 5 ml/kg of 20% albumin or 5 ml/kg of their maintenance fluids (placebo), both given as part of the total daily fluid requirement. The response to the infusion was assessed by comparing two periods; 12 h immediately prior to the infusion and 12-24 h after the infusion. Albumin infusion was associated with a significant increase in albumin level and a significant reduction in weight, but in the placebo group there was a significant increase in weight. There were, however, no significant changes in the peak inspiratory pressure in response to either infusion. There was only a modest reduction (< 15%) in the inspired oxygen concentration, which occurred in both groups, but reached statistical significance only following the albumin infusion. We conclude that our results suggest that albumin infusion in "hypoalbuminaemic" sick preterm infants is unlikely to alter their respiratory status. In a prospectively randomized trial of 220 patients, 106 were given albumin when their colloid osmotic pressure (COP) fell below 24 cm H2O and 114 were given albumin when their COP fell below 29 cm H2O. There was no difference in the postoperative course between the two groups; however, by using the lower COP limit the postoperative albumin consumption in the intensive care unit was reduced significantly and thus the costs of treatment were lowered. In the case of extremely low COP, the prognosis of the disease worsened, indicating that the COP is of prognostic value. The albumin supply, however, did not influence the final outcome of the patients under these circumstances because it treated only a characteristic symptom and not the cause of the disease. There are still several concerns about the extensive and prolonged use of hydroxyethylstarch solution (HES) in critically ill patients. The effects of volume replacement with HES over 5 days on hemodynamics, laboratory data, and organ function were compared with volume therapy using human albumin (HA).
                Prospective, randomized study.
                Clinical investigations on a surgical intensive care unit (ICU) of a university hospital.
                150 traumatized patients (injury severity score > 15) and 150 postoperative patients with sepsis were analyzed.
                Either 10% low-molecular weight HES (HES-trauma, n = 75; HES-sepsis, n = 75) or 20% HA (HA-trauma, n = 75; HA-sepsis, n = 75) was given for 5 days to maintain the pulmonary capillary wedge pressure (PCWP) between 12 and 15 torr. The entire management of therapy of the patients was performed by physicians who were not involved in the study and blinded to the infusion regimen.
                In addition to extensive cardiorespiratory monitoring, several routine laboratory parameters for assessing pulmonary, renal, hepatic, and coagulation function were analyzed from arterial blood samples on the day of admission to the ICU and on the day of sepsis diagnosis, respectively ("baseline" value) and daily over the following 5 days. Mortality during and after the study did not differ significantly between the infusion groups. There were also no differences between the incidence of pulmonary, renal, or hepatic failure in the two subgroups. Mean arterial pressure, heart rate, and PCWP were similar in both subgroups, whereas cardiac index, oxygen delivery index, oxygen consumption index, and the ratio between the partial pressure of oxygen in arterial blood and fractional inspired oxygen were higher in the HES- than in the HA-treated groups. Standard coagulation parameters did not differ, albumin concentration increased significantly in both HA groups, and lactate concentrations decreased only in the HES-sepsis patients (from 2.8 +/- 0.5 to 1.5 +/- 0.4 mg/dl). Volume replacement using albumin was significantly (p < 0.001) more costly than therapy with HES.
                Volume therapy with 10% HES for 5 days in the ICU patient showed no disadvantages compared with an infusion regimen using 20% albumin. Volume replacement using HES may even be associated with improved hemodynamics. HES appears to be a valuable and significantly cheaper alternative to albumin--even for prolonged volume therapy in the critically ill patient. Interleukin-2 (IL-2)-based therapy induces a vascular leak syndrome (VLS), manifested by hypotension, tachycardia, and oliguria, as is also seen with septic shock. The optimal method for treating such VLS is not known. A prospective randomized trial was undertaken to compare crystalloid and colloid fluid resuscitation for patients receiving bolus IL-2-based therapy for metastatic cancer. All patients received maintenance crystalloid fluid administration and were randomized to receive crystalloid (0.9% normal saline) or colloid (5% human serum albumin) fluid boluses to maintain acceptable vital signs and urine output. Patients refractory to fluid boluses were given dopamine for oliguria and/or phenylephrine for hypotension. Of 107 patients who completed one cycle of therapy on study, 76 completed a full treatment course (two cycles) on study. The total number of saline and albumin fluid boluses given were 9.5 +/- 0.9 versus 7.7 +/- 0.7 (p = 0.36, n = 107) for the first cycle and 19.2 +/- 1.8 versus 16.1 +/- 1.6 (p = 0.33, n = 76) for a complete course, respectively. Although patients receiving saline boluses had significantly more oliguria during a course of therapy, weight gain, number of IL-2 doses, tachycardia, hypotension, vasopressor use, hospital stay, and clinical response rates did not significantly differ between arms. Changes in hematocrit, hemoglobin, protein, albumin, blood urea nitrogen (BUN), and creatinine were analyzed, and patients receiving crystalloid showed greater decreases in albumin (p < 0.0001) and total protein (p < 0.05) as expected. A 40-fold greater cost associated with albumin suggested that crystalloid resuscitation be used to treat the VLS associated with IL-2 therapy.(ABSTRACT TRUNCATED AT 250 WORDS) In Canada, hydroxyethyl starch 264/0.45 (HES 264/0.45; molar weight 264 kDa, molar substitution 0.45) has largely replaced albumin as the colloidal fluid of choice for perioperative intravascular volume expansion. The maximum recommended dose of HES 264/0.45 is 28 mL/kg; however, there are no clinical data supporting this limit. In this study we compared the hemostatic effects of HES 264/0.45 versus 5% albumin in doses up to 45 mL/kg over 24 h during major reconstructive head and neck surgery. Fifty patients were randomized to receive HES 264/0.45 or 5% human albumin from the induction of anesthesia until 24 h thereafter. Both albumin and HES 264/0.45 effectively maintained physiologic variables in the perioperative and postoperative periods. The partial thromboplastin time and international normalized ratio were significantly increased in the HES 264/0.45 group compared with the albumin group after infusion of 30 mL/kg and 45 mL/kg (P < 0.05). Factor VIII activity and von Willebrand factor level were significantly reduced in the HES 264/0.45 group compared with the albumin group after infusion of 15 mL/kg, 30 mL/kg, and 45 mL/kg (P < 0.05). Significantly more subjects in the HES 264/0.45 group received allogeneic red blood cell transfusions (P < 0.02). We conclude that HES 264/0.45 infusions >30 mL/kg over 24 h impair coagulation to a greater extent than albumin, possibly leading to more allogeneic transfusions. To determine whether replacement of human albumin will improve a patient's prognosis.
                A randomized, double-blind, controlled study in which 25 g of human albumin vs. placebo was administered intravenously daily.
                A university-affiliated hospital.
                Thirty-six patients with hypoalbuminemia (serum albumin of <2.5 g/dL), receiving total parenteral nutrition. None of the patients had known cancer, cirrhosis, or nephrotic syndrome.
                Each patient received at least 6 days of therapy (6 to 24 days of albumin; 7 to 32 days of placebo). Four subjects were excluded from the study since they received therapy for <6 days. One patient was excluded from the study after nephrotic syndrome was identified. Albumin metabolic rates for those patients receiving albumin were estimated using the formula: Metabolism of albumin = 25 g/day + (albumin 1 - albumin 2)(Vd)/days, where albumin 1 and 2 are the serum albumin concentrations (g/L) at the beginning and end of the serum sampling intervals, respectively; Vd is the volume of distribution (L); and days relates to the number of days of the sampling interval.
                Sixteen patients received albumin; 15 patients received placebo. One patient receiving placebo and two patients receiving albumin died within 30 days. One patient who received placebo and three patients who received albumin developed sepsis or bacteremia; four patients who received placebo and seven patients who received albumin developed pneumonia during the study (NS). The serum albumin increased in all patients receiving intravenous albumin, but one patient received intravenous albumin for only 6 days. The mean serum albumin concentration increased by 1.42 g/dL in the albumin patients, and increased by 0.29 in the placebo patients (p < .0001 by unpaired t-test). Mean initial albumin metabolism was 17.4 g/day (0.3 g/kg/day). At the end of therapy, albumin metabolism was 20.5 g/day (0.36 g/kg/day) (paired t-test, p = .4, NS).
                a) The administration of intravenous albumin to hypoalbuminemic patients receiving total parenteral nutrition does not improve morbidity or mortality. b) Albumin metabolic rates, initially related to the catabolic state, are high; later, these rates are high related to filling of the albumin space and gluconeogenesis. c) On the basis of the high albumin catabolic rates at the end of the infusion, doses of albumin of <25 g/day might be sufficient to replace albumin stores. We conducted a controlled, prospective trial to evaluate the effectiveness of rapidly infusing sodium bicarbonate (NaHCO3) and salt-poor albumin into high-risk, premature infants in the first 2 hours of life. Fifty-three infants, randomized into one of four treatment groups, received 8 ml. per kilogram of a solution containing either (A) glucose in water, (B) salt-poor albumin, (C) NaHCO3, or (D) a combination of albumin and NaHCO3. After the initial infusion, the babies received no colloid or alkali solutions until 4 hours of age. We managed them supportively with warmth, appropriate oxygen administration, isotonic fluid infusion, and close monitoring. Among the infants who received alkali, 14 of 26 acquired the respiratory distress syndrome (RDS), 11 died, and four had intracranial hemorrhage. Among babies who received no alkali, RDS occurred in 11 of 27, 5 died, and none had intracranial hemorrhage. These results do not support the common practice of rapidly infusing NaHCO3 into high-risk, premature infants, and they suggest that the early management of such infants needs renewed critical evaluation. To compare the efficacy of a colloid (5% albumin) and a crystalloid (isotonic saline) solution for treating hypotension in mechanically ventilated preterm infants.
                Sixty three preterm infants weighing 540 to 1950 g at birth and with gestational ages of 23 to 34 weeks, who developed hypotension (mean arterial pressure < 25, 30, and 35 mm Hg for infants with birthweight < 1, 1-1.49, and 1.5-1.99 kg, respectively) within the first 2 hours of life, were randomly allocated to receive intravenous infusions at 10 ml/kg of either 5% albumin (group 1, n = 32) or isotonic (0.9%) saline (group 2, n = 31). Inotropic support with dopamine infusion was given if the infants remained hypotensive after a total of three infusions (30 ml/kg). Subsequent extra doses of volume expander in the form of 5% albumin was given, depending on the infant's blood pressure.
                There was no difference in the volume of the test solutions required between the two groups. Outcome, as assessed by the number of infants requiring inotropic support and death or chronic lung disease, did not differ between the groups. After inotropic support, however, group 1 required significantly more volume expander to maintain normal blood pressure (median: 27.5 ml/kg vs 10 ml/kg; P = 0.0187) and had a higher mean (SEM) percentage weight gain within the first 48 hours of life (at 24 hours: 6.3(1.3)% vs 3.3(0.8)%; P = 0.049; at 48 hours: 5.9(1.9)% vs 0.9(1.7)%; P = 0.045). The difference in weight gain was significant at 48 hours even when only those infants not requiring inotropic support or extra 5% albumin were compared (group 1: 1.5(1.5)%, group 2: -4.2(1.1)%; P = 0.027).
                Isotonic saline is as effective as 5% albumin for treating hypotension in preterm infants, and it has the additional advantage of causing less fluid retention in the first 48 hours. The administration of albumin improves circulatory function, prevents hepatorenal syndrome, and reduces hospital mortality in patients with cirrhosis and spontaneous bacterial peritonitis. This randomized unblinded pilot study compared the effect of albumin (10 patients) and the synthetic plasma expander hydroxyethyl starch 200/0.5 (10 patients) on the systemic hemodynamics of patients with spontaneous bacterial peritonitis. Baseline measurements were performed within 12 hours after diagnosis of infection. Patients then received 2 doses of the volume expander (1.5 g/kg body weight after baseline measurements and 1 g/kg body weight on day 3). Measurements were repeated after infection resolution. Treatment with albumin was associated with a significant increase in arterial pressure and a suppression of plasma renin activity, indicating an improvement in circulatory function. This occurred in the setting of a significant expansion of central blood volume (increase in cardiopulmonary pressures and atrial natriuretic factor) and an increase in systolic volume and systemic vascular resistance. In contrast, no significant changes were observed in these parameters in patients treated with hydroxyethyl starch. Von Willebrand-related antigen plasma levels significantly decreased in patients treated with albumin but not in those treated with hydroxyethyl starch. Serum nitrates and nitrites increased in patients treated with hydroxyethyl starch but not in those treated with albumin. These data suggest an effect of albumin on endothelial function. In conclusion, albumin but not hydroxyethyl starch improves systemic hemodynamics in patients with spontaneous bacterial peritonitis. This effect is due not only to volume expansion but also to an action on the peripheral arterial circulation. Percutaneous endoscopic gastrostomy (PEG) is widely used for long-term enteral nutrition in patients with dementia and inadequate oral intake, although its benefit in prolonging the survival of the patient is not clear. Patients are often referred for PEG placement after a significant weight loss or fall in serum albumin. It is not known whether this delay in referral adversely affects the survival. Our aim was to determine the survival after PEG placement in patients with inadequate oral intake secondary to cognitive impairment and to determine whether-the nutritional parameters at the time of placement of PEG predict survival.
                After excluding patients with cancer, cerebrovascular accident (CVA), and anoxic encephalopathy, 56 consecutive patients with dementia and inadequate oral intake were included in the study. The following parameters were analyzed to predict survival benefit: demographics, reason for admission to the hospital, nutritional indices, Karnofsky performance status before and after PEG, comorbid medical illnesses, and complications after PEG. A control group was selected from patients admitted to the geriatric division who did not receive PEG. Patients with CVA, cancer, and anoxic encephalopathy were also excluded in the control group. Both groups were followed-up for 6 months.
                One patient was lost to follow-up and complete data were available for 55 patients. The control group of 33 patients was comparable to the patients in age, gender, and comorbid illnesses. During a 6-month follow-up period, the mortality was 44% among patients and 26% among controls (p = 0.03). The only factor that predicted poor survival in patients at 6 months was a serum albumin of <2.8 g/dl. The predictive value of low serum albumin was higher in patients with sepsis on hospital admission and in patients younger than 85 yr. The mean serum albumin of the patients was significantly lower than the control group (p = 0.0001).
                Only 50% of demented patients with inadequate oral intake are likely to survive beyond 6 months after PEG placement. No improvement in performance status is likely to occur in any patient. These limited benefits should be realized before initiating PEG feeding. Since the survival in the age-matched control group with a higher mean serum albumin was better than in the patients who had PEG, there may be some benefit in performing PEG before the onset of severe hypoalbuminemia. Large-volume paracentesis associated with plasma volume expansion with albumin is an effective, safe, but costly therapy for ascites in patients with cirrhosis. The aim of this study was to compare the use of a synthetic plasma expander, hydroxyethyl starch (HES), with that of albumin.
                Sixty cirrhotic patients with ascites were studied. Patients were randomly assigned to be infused with either albumin (8 g/l of ascites removed, n = 33) or HES (200 ml/l of ascites removed, n = 27). None of the patients was treated with diuretics or had renal impairment or hyponatremia at entry. Clinical and laboratory data were obtained before and 1, 3 and 15 days after treatment.
                There were no significant differences in clinical and laboratory parameters between the two groups at entry into the study. None of the patients developed renal impairment during the trial. One patient (HES group) presented with hyponatremia. Plasma atrial natriuretic factor and aldosterone levels did not differ between the two groups at baseline or at 1 and 3 days after paracentesis. The volume of ascites removed did not differ between the albumin (7.9 +/- 4.4 l) and HES (6.9 +/- 5.3 l) groups. However, there was a significant difference in weight loss between the albumin and HES groups (7.9 +/- 5.2 kg vs 4.7 +/- 3.4 kg; p = 0.01). Clinical and laboratory parameters indicated that HES was well tolerated except for hypoalbuminemia.
                HES is well tolerated in patients with cirrhosis. There is no difference between HES and albumin in the prevention of complications related to large-volume paracentesis. The lesser degree of weight loss observed with HES needs further study. All patients admitted to an Intensive Care Unit were randomised to receive all volume replacement fluid as either human albumin solution or a synthetic colloid. A total of 475 patients were admitted during the study period. Patients' age, sex, APACHE score and calculated risk of death were assessed on admission. Outcome was assessed as length of Intensive Care stay and mortality. There was no difference between the groups. Subgroups of patients with APACHE score greater than 10, calculated risk of death greater than 50% and length of stay greater than 5 days were also evaluated but not significant differences were found between treatment groups. The use of albumin rather than 3.5% polygeline for volume replacement in the Intensive Care Unit has no influence on outcome. It remains uncertain whether the choice of resuscitation fluid for patients in intensive care units (ICUs) affects survival. We conducted a multicenter, randomized, double-blind trial to compare the effect of fluid resuscitation with albumin or saline on mortality in a heterogeneous population of patients in the ICU.
                We randomly assigned patients who had been admitted to the ICU to receive either 4 percent albumin or normal saline for intravascular-fluid resuscitation during the next 28 days. The primary outcome measure was death from any cause during the 28-day period after randomization.
                Of the 6997 patients who underwent randomization, 3497 were assigned to receive albumin and 3500 to receive saline; the two groups had similar baseline characteristics. There were 726 deaths in the albumin group, as compared with 729 deaths in the saline group (relative risk of death, 0.99; 95 percent confidence interval, 0.91 to 1.09; P=0.87). The proportion of patients with new single-organ and multiple-organ failure was similar in the two groups (P=0.85). There were no significant differences between the groups in the mean (+/-SD) numbers of days spent in the ICU (6.5+/-6.6 in the albumin group and 6.2+/-6.2 in the saline group, P=0.44), days spent in the hospital (15.3+/-9.6 and 15.6+/-9.6, respectively; P=0.30), days of mechanical ventilation (4.5+/-6.1 and 4.3+/-5.7, respectively; P=0.74), or days of renal-replacement therapy (0.5+/-2.3 and 0.4+/-2.0, respectively; P=0.41).
                In patients in the ICU, use of either 4 percent albumin or normal saline for fluid resuscitation results in similar outcomes at 28 days.
                Copyright 2004 Massachusetts Medical Society To compare the hemodynamic and oxygen transport responses to a rapid (< 10-min) infusion of 500 mL of modified fluid gelatin (group A) or hydroxyethyl starch (group B) in patients suffering from acute hypovolemia.
                Prospective, randomized, noncrossover study.
                University hospital, general intensive care unit.
                Twenty-eight patients with hypovolemia mechanically ventilated for concurrent acute respiratory failure.
                Patients were mechanically ventilated. Pulmonary and femoral artery catheters were used for hemodynamic monitoring.
                Hemodynamic and oxygen transport variables were determined at baseline, 15 mins, and 30 mins after the infusion of each fluid. In both groups pulmonary artery occlusion pressure, stroke volume, and cardiac index significantly increased. In neither group did heart rate decrease. Oxygen delivery increased significantly in group A patients but not in group B patients. This result was due to greater hemodilution in group B patients.
                There are no significant differences in the hemodynamic responses to hydroxyethyl starch or modified fluid gelatin. The hemodynamic and oxygen transport effects of artificial colloid solutions may not be entirely predictable and should be monitored in critically ill patients. Because several studies have shown a significant inverse correlation between depressed serum concentrations of albumin and hospital morbidity, a study with central total parenteral nutrition (TPN) with normal serum albumin (NSA) in hypoalbuminemic patients was conducted. Sixty-one patients who required central TPN were randomized into one of two groups: group 1 (n = 31) received TPN plus NSA (25 to 37.5 g/day) until their measured serum albumin was greater than 3 g/dl, and group 2 (n = 30), who received TPN alone. All patients were followed for hospital complications until discharge or death. The groups were well matched for age, sex, major diagnoses, initial serum albumin concentrations, hospital complications before TPN, and number of operative procedures. Both groups received comparable doses of energy (37.2 +/- 89 vs. 3.30 +/- 6.2 kcal/kg.day) and protein (1.6 +/- 0.4 vs. 1.6 +/- 0.3 g/kg.day). After initiation of TPN, there were significantly more hospital complications in group 2 (1 = 1.1 +/- 1.4, n = 33; 2 = 2.6 +/- 3.0, n = 80, p less than .01). When complications in the patient groups were stratified, significantly more patients in group 2 developed pneumonia (18 vs. 9, p less than .05) and septicemia (11 vs. 2, p less than .05). Increasing serum albumin concentrations with NSA in hypoalbuminemic patients receiving central TPN appears to be associated with a reduction in hospital morbidity. Hypovolemia is a common clinical entity in critical patients, and adequate volume replacement therapy seems to be essential for maintaining tissue perfusion. However, it is still uncertain which solution is most appropriate for fluid resuscitation.
                The aim of this study was to investigate the effects of fluid resuscitation with 3.5% polygeline versus 6% hydroxyethyl starch solutions on hemodynamic functions and liver functions assessed with a noninvasive liver function monitoring system (LIMON) in hypovolemic patients.
                This study is a prospective randomized clinical trial.
                Thirty hypovolemic patients (intrathoracic blood volume index, <850 mL/m(2)) were randomized into hydroxyethyl starch (mean molecular weight, 130,000 Da) and polygeline (mean molecular weight, 30,000 Da) groups (15 patients each). Indocyanine green plasma disappearance elimination (ICG-PDR) were conducted concurrently using LIMON. A dose of 0.3 mg/kg ICG was given through a cubital fossa vein as a bolus. For fluid resuscitation, 500 mL of colloid was given to the patients. Repeated hemodynamic and ICG-PDR measurements were done at baseline, after infusion, and then at 30 minutes after infusion.
                Intrathoracic blood volume index and systolic, diastolic, and mean blood pressures increased significantly after infusion and remained elevated for 30 minutes after infusion, but there was no significant difference between the 2 groups. Indocyanine green plasma disappearance elimination values were similar in both groups with no significant difference between the two.
                Increasing intrathoracic blood volume index and hemodynamic variables by fluid loading is not associated with a significant change in ICG-PDR.
                Copyright (c) 2010 Elsevier Inc. All rights reserved. Hemodilution in the acute phase of ischemic stroke is still controversial. Multicenter studies have failed to demonstrate any benefit. The present study focuses attention on analysis of circulation in stroke and on individual restabilization of circulation.
                The Amsterdam Stroke Study is a prospective, single-center, randomized clinical trial (n = 300). Normovolemic hemodilution is accomplished in a customized procedure by administration of 20% albumin plus crystalloids under hemodynamic and rheological monitoring in the acute phase of stroke. All patients receive general intensive care treatment and monitoring with a pulmonary artery catheter. This custom-tailored fluid therapy is guided on the basis of a target pulmonary capillary wedge pressure (12 +/- 3 mm Hg) and hematocrit (0.32 +/- 0.02). The control group receives only customized rehydration by infusion of crystalloids.
                We obtained significant (p less than 0.05) reduction in mortality at 3 months (from 27% to 16%) and an increase in independence at home (from 35% to 48%) after viscosity reduction by means of hemodilution with albumin in the subgroup with a hematocrit less than 0.45 (n = 201) (specific viscosity effect). We also obtained a significant (p less than 0.005) reduction in mortality at 3 months (from 27% to 8%) and an increase in independence (from 35% to 59%) after only rehydration with crystalloids in the subgroup with overt dehydration (hematocrit greater than or equal to 0.45; n = 51) as compared with the normal-hematocrit group without signs of dehydration (hematocrit less than 0.45; n = 103) (specific rehydration effect).
                This study may provide an explanation for the failures in former hemodilution trials and may re-establish proper hemodilution and rehydration as a valuable therapy in the acute phase of stroke, thus reducing mortality and improving independence after 3 months. Patients who have undergone cardiac surgery with use of extracorporeal circulation frequently reveal marked hypovolaemia in spite of a highly positive fluid balance. This is thought to be due to transient microvascular damage and extravascular fluid shift. Further volume replacement to achieve haemodynamic stability in the postoperative period may cause fluid overload and congestive heart failure. The present study was designed to investigate whether this fluid overload could be avoided by using a hypertonic-hyperoncotic solution (group I: HHL, 10% hydroxyethylstarch 200/0.5 in 7.2% saline) instead of two different standard colloid solutions (group II: HA, 5% albumin; group III: HES, 6% hydroxyethylstarch in 0.9% saline).
                Twenty-one patients meeting our criteria for hypovolaemia immediately after cardiac surgery were randomly assigned to three groups. Patients in group I received HHL in increments of 150 ml, while patients in group II and group III were given HA and HES respectively in increments of 500 ml until hypovolemia was corrected. Haemodynamic assessment was done using a pulmonary artery thermodilution catheter. Intra- and extravascular volumes, including extravascular lung water (EVLW), intrathoracic blood volume (ITBV), and total blood volume (TBV) were measured by the double indicator technique using lung water software (COLD-System, Pulsion, Munich, Germany).
                Correction of hypovolaemia-related haemodynamic parameters and restoration of normal TBV were achieved by 236 +/- 80 ml of HHL (group I), 857 +/- 244 ml of HA (group II) and 1000 +/- 0 ml of HES (group III) respectively. TBV increased significantly in each group, compared to baseline values. EVLW did not change significantly in any group. We found that the volume-augmenting effect of HHL per millilitre infused solution was more than four times that of HA and HES, primarily as a result of increasing plasma osmolality due to an increase of plasma sodium levels. This pronounced effect on intravascular volume of HHL lasted for only 2 h following infusion, however, and did not lead to any unwanted side effects. In the period between 2 and 20 h after primary volume replacement, further fluid therapy with colloids and crystalloids, guided by clinical signs of hypovolaemia, was necessary in each group of patients. The overall fluid requirements for the first 20 h after operation did not differ among the three resuscitation regimens.
                We found that HHL is a safe and effective solution for acute correction of hypovolaemia after cardiac surgery. The advantages of a smaller initial volume load by HHL cannot be maintained for longer than 2 h. Several colloid preparations are available for fluid resuscitation following heart surgery. We conducted a randomized prospective trial to compare a polygeline infusion versus human albumin with respect to hemodynamic and pulmonary function. 20 patients were randomly assigned to receive either Haemaccel or human albumin using a standardized protocol for the first 8 hours following heart surgery. The double-indicator dilution method was used to measure total blood volume index (TBVI), intrathoracic blood volume index (ITBVI) and extravascular lung water index (EVLWI) three times during the study period. Pulmonary shunt fraction, time on ventilator, and chest tube drainage were measured as well. Hemodynamic stability was achieved in both groups throughout the study period, as judged from mean arterial pressure, pulmonary capillary wedge pressure, and cardiac index. ITBV and TBVI were higher in the albumin group, although only significant at 4 hours for TBVI. There was no significant difference in EVLWI, pulmonary shunt fraction, and time on mechanical ventilation. Likewise, chest tube drainage was not significantly different in both groups. Haemaccel is effective in maintaining hemodynamic stability following heart surgery without ill effects of lung function or chest tube drainage. Treatment costs are substantially lower compared to human albumin. For perioperative volume therapy in infants and young children, human albumin has frequently been the colloid of choice. Recently, HES 130/0.4 (6% hydroxyethyl starch, Voluven; Fresenius Kabi, Bad Homburg, Germany) was developed, which demonstrated improved pharmacokinetics and a favourable safety profile in adults compared with hydroxyethyl starch products with a less rapid metabolization.
                Our prospective, controlled, randomized, open, multicentre pilot study was designed to obtain data on the effects of HES 130/0.4 compared with human albumin 5% with regard to haemodynamics in children <2 yr scheduled for elective non-cardiac surgery.
                A total of 81 patients were treated. Comparable amounts of both study solutions (16.0 mL kg(-1) hydroxyethyl starch 130/0.4 vs. 16.9 mL kg(-1) human albumin 5%) as well as add-on crystalloids were used until 4-6 h postoperatively. No differences were detected between the two treatment groups regarding perioperative stabilization of haemodynamics, coagulation parameters, blood gas analyses or other laboratory values. Blood loss was 96 +/-143 mL for hydroxyethyl starch and 145+/- 290 mL for human albumin (P > 0.05). There were no relevant differences in the amount of red blood cells, fresh frozen plasma or platelet concentrates in both treatment groups. Median length of ICU stay was 3.5 days (range 1-57 days, mean +/- SD 7.6 +/- 11.5 days) in the hydroxyethyl starch group and 6.0 days (range 1-71 days; mean +/- SD 9.1 +/- 14.2 days) in the human albumin group. There was no difference for hospital stay (median: 12 days for both groups).
                Both HES 130/0.4 and human albumin 5% were effective for haemodynamic stabilization in non-cardiac surgery of young infants with no adverse impact on coagulation or other safety parameters in our study population. In 40 patients, whose expected hemodynamic instability during surgery necessitated invasive monitoring (Swan-Ganz catheter) and arterial pressure monitoring the hemodynamic and oxygen transport parameters in conditions of hypervolemic hemodilution were investigated in randomized tests. After insertion of an arterial catheter (arteria radialis) as well as Swan-Ganz pulmonary arterial catheter via the vena jugularis interna, one of the two volume substitutes selected at random was infused in quantities of 125 ml/5 min and the hemodynamic changes were measured after infusion of 500 ml and finally after a wedge pressure of 18 mmHg was reached. Using either solution, the measurements indicated significant increases in mean arterial pressure as well as in central venous pressure (ZVD) and wedge pressure. The cardiac index, left ventricular stroke work index, and stroke output rose consecutively and pulmonary vascular resistance went down in both test groups. In the case of both volume substitutes, there was an improvement in oxygen availability. The hemoglobin content decreased in both groups, though to different degrees in each group. Although the hydroxyethyl starch group registered a greater improvement in the cardiac index, a bigger decrease in pulmonary vascular resistance, a higher rise in the left ventricular stroke work index and a more significant improvement in stroke output, smaller quantities of the volume substitute were required in this group than in the group in which volume substitution was carried out with human albumin 5%.(ABSTRACT TRUNCATED AT 250 WORDS) To evaluate the efficacy of i.v. administration of human albumin solution for the prevention of severe ovarian hyperstimulation syndrome (OHSS).
                A prospective, randomized, placebo-controlled study comparing the effects of i.v. administration of human albumin solution versus sodium chloride 0.9% solution at the time of oocyte retrieval with patients undergoing IVF-ET who are at high risk for the development of severe OHSS.
                Specialized assisted reproduction unit.
                Thirty-one patients undergoing IVF-ET who had serum E2 levels of 1,906 pg/mL (> 7,000 pmol/L) and multiple follicular development on the day of hCG administration.
                After hCG administration, patients were randomized to receive i.v., either 50 g of human albumin diluted in 500 mL of sodium chloride 0.9% or 500 mL of sodium chloride 0.9% at the time of oocyte retrieval.
                Ovarian size as measured by pelvic ultrasonography, development of ascites, serum E2 concentrations during the luteal phase, and results of the IVF-ET cycles.
                Although no patient who had received human albumin solution developed severe OHSS, there were four such cases in the control group. All four were hospitalized with marked ascites and ovarian enlargement. There were no significant differences between the two groups comparing serum E2 levels on the day of hCG administration and during the luteal phase, the number of oocytes retrieved, fertilization, and pregnancy rates.
                Our preliminary results suggest that the administration of human albumin solution may help to prevent the development of severe OHSS in high-risk patients. Further research is needed to assess the potential of this novel approach. A prospective randomized placebo controlled clinical trial was carried out on 250 patients (cycles) considered at risk of developing OHSS in an IVF programme. Criteria for inclusion were: estradiol value of more than 3000 pg/ml or the presence of more than 20 follicles on the day of hCG administration. Patients were randomized by using a random table to receive either 20% human albumin 50 ml (n: 82); 6% hydroxyethyl starch (200/0.5) 500 ml (n: 85) or a placebo of 500 ml 0.9% NaCl solution (n: 83) over 30 min during oocyte collection. Groups were similar with respect to patients' age, estradiol levels on hCG day, body mass index, number of oocytes retrieved, number of embryos transferred and pregnancies (P>0.05). There was no severe OHSS in patients who received albumin and HES while four patients who received placebo developed severe OHSS. On the other hand moderate OHSS was encountered in four patients in the albumin group; five patients receiving HES; and 12 patients receiving placebo. There was a statistically significant difference in the incidence of moderate, severe and overall OHSS among groups (P values of <0.05, <0.05, and <0.01, respectively). Both HES and albumin significantly reduced the incidence of moderate, severe and overall incidence of OHSS. It is concluded that hydroxyethyl starch is a cheaper and safer alternative to Human Albumin in OHSS prevention. To compare the hemodynamic effects of two different concentrations of pentastarch hydroxyethyl starch (HES; 200/0.5) solutions with a 4% human albumin solution for fluid resuscitation.
                Open-label, randomized, controlled study.
                Medical-surgical intensive care unit.
                34 consecutive, hemodynamically stable, adult patients with sepsis and suspected hypovolemia.
                Patients received a 400 mL infusion of either 10% HES (n = 11), 6% HES (n = 10), or 4% albumin (n = 13) over 40 minutes.
                Hemodynamic and blood data were collected 40, 70, 100, and 160 minutes after the start of the fluid challenge.
                Cardiac index, stroke volume index, and left ventricular stroke work index increased more in the 10% HES group than the 6% HES or albumin groups (P < 0.05). Oxygen delivery increased only in the 10% HES group. A decrease in hemoglobin concentration occurred in all three groups but was greatest in the 10% HES group.
                HES is as effective as albumin for volume resuscitation in septic patients. Patients with liver cirrhosis and a superimposed acute injury with progressive hyperbilirubinemia have a high mortality. A prospective, controlled study was performed to test whether hyperbilirubinemia, 30-day survival, and encephalopathy would be improved by extracorporeal albumin dialysis (ECAD). Twenty-four patients were studied; 23 patients had cirrhosis; 1 had a prolonged cholestatic drug reaction and was excluded from per protocol (PP) analysis. Patients had a plasma bilirubin greater than 20 mg/dL and had not responded to prior standard medical therapy (SMT). Patients were randomized to receive SMT with ECAD or without (control). ECAD was performed with an extracorporeal device that dialyzes blood in a hollow fiber dialyzer (MW cutoff < 60 kd) against 15% albumin. Albumin-bound molecules transfer to dialysate albumin that is regenerated continuously by passage through a charcoal and anion exchange column and a conventional dialyzer. ECAD was associated with improved 30-day survival (PP, 11 of 12 ECAD, 6 of 11 controls; log rank P <.05). Plasma bile acids and bilirubin decreased on average by 43% and 29%, respectively, in the ECAD group after 1 week of treatment, but not in the control group. Renal dysfunction and hepatic encephalopathy improved in the ECAD group, but worsened significantly in the control group. ECAD was safe, with adverse events being rare and identical in both groups. In conclusion, ECAD appears to be effective and safe for the short-term treatment of patients with cirrhosis and superimposed acute injury associated with progressive hyperbilirubinemia and may be useful for increasing survival in such patients awaiting liver transplantation. The effects of concurrent administration of albumin with total parenteral nutrition were studied in 12 premature newborns (birth weight 1.26 +/- 0.1 kg [mean +/- SEM] and gestational age 30 +/- 0.8 weeks [mean +/- SEM]) compared with a control group of 12 premature newborns (birth weight 1.17 +/- 0.2 kg and gestational age 29 +/- 0.1 weeks) who received total parenteral nutrition. All newborns had a plasma albumin level below 3 g/dL and were in cardiorespiratory distress requiring assisted ventilation. Albumin supplementation of total parenteral nutrition resulted in a sustained increase in serum albumin concentration as well as increased mean arterial blood pressures in the study group. Slow albumin infusion had no observed effect on the severity of respiratory distress. Study group infants regained birth weight earlier than control group infants. These data suggest that the concurrent administration of albumin may be clinically beneficial in critically ill newborn infants. The effect of 5 percent human albumin on multiple organ dysfunction was investigated during the first 14 days of treatment to determine whether albumin resuscitation might benefit adult burn patients.
                Multicenter unblinded controlled trial with stratified block (two patients per block) randomization by center and mortality prediction at enrollment (high-risk stratum [predicted mortality, 50%-90%] and low-risk stratum [predicted mortality, <50%]). The primary outcome was the worst multiple organ dysfunction score (MODS), excluding the cardiovascular component, to Day 14. Eligible adults (>15 years) suffering from thermal injury not more than 12 hours before enrollment received fluid resuscitation with Ringer's lactate (n=23) or 5 percent human albumin plus Ringer's lactate (n=19) by protocol to achieve recommended (American Burn Association) resuscitation endpoints.
                Forty-two patients were randomly assigned. There were no significant differences (median [95% confidence intervals]) in age (36 [24-45] vs. 31 [25-39] years), burn size (39 [32-53] vs. 32 [26-34] total body surface area percentage), inhalation injury (n=12/19 vs. n=11/23), or baseline MODS (3 [1-5] vs. 1.5 [0-2]) between the treatment and control groups. In an intention-to-treat analysis, there was no significant difference between the treatment and control group in the lowest MODS from Day 0 to Day 14 (analysis of covariance, p=0.73).
                Treatment with 5 percent albumin from Day 0 to Day 14 does not decrease the burden of MODS in adult burn patients. The value of human albumin (HA) for treating hypovolemia is controversial. Less expensive alternatives such as hydroxyethyl starch (HES) are sometimes refused because of unwanted side effects. We prospectively randomized 50 patients older than 70 years old undergoing major abdominal surgery to receive either 5% HA (n = 25) or a third generation HES preparation (6% HES 130/0.4; n = 25) when mean arterial blood pressure was <60 mm Hg and central venous pressure was <10 mm Hg. Hemodynamics, inflammation (interleukin-6), endothelial activation-integrity (adhesion molecules), coagulation (thrombelastography), and renal function (including kidney-specific proteins) were monitored after the induction of anesthesia, after surgery, 5 h in the intensive care unit, and on the first postoperative day. HA patients received 3960 +/- 590 mL of HA and 5070 +/- 1030 mL of Ringer's lactate solution, and HES patients received 3500 +/- 530 mL of HES and 4550 +/- 880 mL of Ringer's lactate solution. Total protein remained normal only in the HA-treated patients. No significant differences (P > 0.1) between the groups were seen with regard to hemodynamics, coagulation, and kidney function. Plasma levels of interleukin-6 and soluble adhesion molecules were significantly (P < 0.05) higher in the HA- than in the HES-treated patients. We conclude that HA in elderly patients undergoing major abdominal surgery can easily be replaced by a modern HES preparation. Because of the decreased inflammatory response and endothelial activation-injury, HES 130/0.4 seems to be the more appropriate fluid strategy for these patients. To ascertain the influence of albumin on antioxidant status in patients with acute lung injury.
                Prospective, randomized, placebo-controlled study.
                Intensive care units, teaching hospitals.
                Twenty patients meeting the American European Consensus criteria for acute lung injury.
                Ten patients received albumin (25 g of a 25% solution every 8 hrs for a total of nine doses) and ten received placebo (normal saline administered in identical fashion and volume). All received supportive therapy appropriate for patients with acute lung injury. Plasma samples were obtained sequentially from all patients before, 30 mins after, and 4 hrs after albumin/placebo administration.
                Serum albumin and total protein, total antioxidant status, iron-binding antioxidant protection, iron-oxidizing antioxidant protection, lipid hydroperoxides, protein carbonyls, and plasma thiols were measured. Albumin administration increased plasma albumin concentrations (p <.05 compared with placebo) and decreased concentrations of protein carbonyls (p <.05 compared with placebo). By contrast, plasma lipid hydroperoxide concentrations were similar in both groups, both in absolute terms and relative to albumin content. For all other variables, no significant differences were apparent. For all patients, there was a positive correlation between albumin and plasma thiol concentrations (r =.983, p <.01) and albumin and antioxidant capacity (r =.885, p =.01). In the albumin treatment group, there was a strong correlation between thiols and antioxidant capacity (r =.876, p =.01). No such correlation was apparent in the placebo group. Plasma iron-binding antioxidant protection was negatively correlated (r = -.741, p <.05) with albumin content in the treatment group but not the placebo group.
                In patients with acute lung injury, albumin administration favorably influences plasma thiol-dependent antioxidant status as well as levels of protein oxidative damage. The purpose of the study was to examine the effects of hypooncotic 4% hydroxyethyl starch 120/0.7, 3% dextran 70, 5% albumin and hyperoncotic 6% hydroxyethyl starch 120/0.7 on the perioperative colloid osmotic pressure (COP), albumin and protein concentrations and fluid balance. The plasma substitutes were used with red cell concentrates to replace blood loss with equal volume in sixty major abdominal or urological surgeries. A special effort was made to keep replacements and losses at even volumes constantly and to avoid fluctuation of blood volume. The blood specimen were obtained before induction, after each 20% blood loss, at the end of the recovery room phase and on the three following postoperative mornings. There were significant differences in the peroperative and immediate postoperative COPs. However, these differences had vanished by the first postoperative morning. COP was preserved above 16 mmHg in all groups throughout the study. The identical peroperative albumin and protein concentrations of the synthetic colloid groups suggests that their volume effect was the same, regardless of the varying COP. During the observation period there were no significant differences among the groups concerning the diuresis and the fluid balances. We conclude, that the hypooncotic 4% HES 120 and 3% dextran 70 solutions provide the same clinical effect as 6% HES 120 solution. Consequently less colloid is needed, which allows the use of greater volumes of the dilute colloid solutions in replacement therapy.
For patients with hypovolaemia, there is no evidence that albumin reduces mortality when compared with cheaper alternatives such as saline. There is no evidence that albumin reduces mortality in critically ill patients with burns and hypoalbuminaemia. The possibility that there may be highly selected populations of critically ill patients in which albumin may be indicated remains open to question. However, in view of the absence of evidence of a mortality benefit from albumin and the increased cost of albumin compared to alternatives such as saline, it would seem reasonable that albumin should only be used within the context of well concealed and adequately powered randomised controlled trials.