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document
Effect of cool vs. warm dialysate on toxin removal : rationale and study design . BACKGROUND Cool dialysate is often recommended for prevention of intra-dialytic hypotensive episodes in maintenance hemodialysis ( HD ) patients . However , its effect on toxin removal is not studied . It is known that inter-compartmental resistance is the main barrier for toxin removal . Cool dialysate can potentially increase this resistance by vasoconstriction and thus impair the toxin removal . The aim of this trial is to compare the toxin removal outcome associated with cool vs. warm dialysate . METHOD/DESIGN This study is based on the hypothesis that dialysate temperature , a potential maneuver to maintain hemodynamic stability during HD , may influence inter-compartmental resistance and hence , toxin removal . Only stable HD patients will be recruited for this study . The quantum of removed toxins will be assessed by the total spent dialysate , which is a gold standard to quantify the efficacy of a single dialysis session . Collected samples will be analyzed for urea , creatinine , phosphate , β2-microglobulin , and uric acid . The study is a single center , self-controlled , randomized prospective clinical research where 20 study subjects will undergo 2 dialysis sessions : ( a ) cool dialysis with dialysate at 35.5°C , and ( b ) warm dialysis with dialysate at 37°C . Pre- and post-dialysis blood samples will be collected to quantify the dialysis adequacy and toxin reduction ratio . DISCUSSION This is the first clinical research to investigate the effect of dialysate temperature on removal of both small and large-sized toxins . Successful completion of this research will provide important knowledge pertaining to dialysate temperature prescription . Results can also lead to the hypothesis that cool dialysate may help in by preventing intra-dialytic hypotensive episodes , but prolonged prescription of cool dialysate may lead to comorbidities associated with excess toxin accumulation . The new knowledge will encourage for personalized dialysate temperature profiling . TRIAL REGISTRATION Clinicaltrials.gov Identifier -- NCT02064153 .
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Intervention_Physical
cool
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Intervention_Physical
warm dialysate
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Intervention_Physical
Cool dialysate
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Intervention_Physical
Cool dialysate
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Intervention_Physical
cool
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Intervention_Physical
warm dialysate
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Participant_Condition
toxin removal
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Participant_Condition
maintenance hemodialysis ( HD ) patients .
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Participant_Condition
Only stable HD patients
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Participant_Sample-size
20