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document
Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly : a prospective randomized multicenter controlled study . BACKGROUND A supplemented very-low-protein diet ( sVLPD ) seems to be safe when postponing dialysis therapy . STUDY DESIGN Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis . SETTING & PARTICIPANTS Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min ( 0.08 to 0.12 mL/s ) . INTERVENTION Randomization to an sVLPD ( diet group ) or dialysis . The sVLPD is a vegan diet ( 35 kcal ; proteins , 0.3 g/kg body weight daily ) supplemented with keto-analogues , amino acids , and vitamins . Patients following an sVLPD started dialysis therapy in the case of malnutrition , intractable fluid overload , hyperkalemia , or appearance of uremic symptoms . OUTCOMES & MEASUREMENTS Mortality , hospitalization , and metabolic markers . RESULTS 56 patients were randomly assigned to each group , median follow-up was 26.5 months ( interquartile range , 40 ) , and patients in the diet group spent a median of 10.7 months ( interquartile range , 11 ) following an sVLPD . Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia . There were 31 deaths ( 55 % ) in the dialysis group and 28 deaths ( 50 % ) in the diet group . One-year observed survival rates at intention to treat were 83.7 % ( 95 % confidence interval [ CI ] , 74.5 to 94.0 ) in the dialysis group versus 87.3 % ( 95 % CI , 78.9 to 96.5 ) in the diet group ( log-rank test for noninferiority , P < 0.001 ; for superiority , P = 0.6 ) : the difference in survival was -3.6 % ( 95 % CI , -17 to +10 ; P = 0.002 ) . The hazard ratio for hospitalization was 1.50 for the dialysis group ( 95 % CI , 1.11 to 2.01 ; P < 0.01 ) . LIMITATIONS The unblinded nature of the study , exclusion of patients with diabetes , and incomplete enrollment . CONCLUSION An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes .
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Intervention_Physical
very-low-protein diet
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Intervention_Physical
supplemented very-low-protein diet ( sVLPD )
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Intervention_Physical
diet
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Intervention_Physical
dialysis
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Intervention_Physical
sVLPD ( diet group )
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Intervention_Physical
dialysis
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Intervention_Physical
sVLPD
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Intervention_Physical
sVLPD
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Intervention_Physical
dialysis therapy
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Intervention_Physical
diet group
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Intervention_Physical
sVLPD
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Intervention_Physical
dialysis treatment
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Intervention_Physical
dialysis group
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Intervention_Physical
diet group
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Intervention_Physical
dialysis
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Intervention_Physical
diet
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Intervention_Physical
dialysis group
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Intervention_Physical
sVLPD
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Outcome_Other
Efficacy and safety
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Outcome_Other
safe
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Outcome_Mortality
Mortality
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Outcome_Physical
hospitalization
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Outcome_Physical
metabolic markers
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Outcome_Physical
fluid overload or hyperkalemia
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Outcome_Mortality
deaths
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Outcome_Mortality
One-year observed survival rates
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Outcome_Mortality
survival
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Outcome_Other
The hazard ratio for hospitalization
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Outcome_Other
effective and safe
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Participant_Condition
postponing dialysis
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Participant_Age
elderly
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Participant_Condition
diabetes
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Participant_Age
older than 70 years
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Participant_Condition
glomerular filtration rate of 5 to 7 mL/min ( 0.08 to 0.12 mL/s )
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Participant_Sample-size
56 patients
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Participant_Age
elderly patients
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Participant_Condition
diabetes