Dataset Information

Effect of cool vs. warm dialysate on toxin removal: rationale and study design.

ABSTRACT: 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.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, ?2-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.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.Clinicaltrials.gov Identifier--NCT02064153.

SUBMITTER: Maheshwari V

PROVIDER: S-EPMC4381674 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of cool vs. warm dialysate on toxin removal: rationale and study design.

Maheshwari Vaibhav V Lau Titus T Samavedham Lakshminarayanan L Rangaiah Gade P GP

BMC nephrology 20150227

<h4>Background</h4>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 dialy ...[more]

PMID: 25885180

Similar Datasets

Project description:Rosa rugosa Thunb. has been explored multi-function in medicinal, edible, cosmetic, ornamental and ecological etc. However, R. rugosa natural populations have recently declined substantially in China, besides of global climate change, this species also has the defect of limiting the reproduction of itself such as the hard-to-release seed dormancy. In this study, only 30% of R. rugosa seeds were viable, and the others were incompletely developed or diseased seeds. Without stratification, morphologically complete viable seeds imbibed water but those seeds could not germinate even after seed husk removal under suitable condition to exhibit a physiological dormancy. After cold (4°C) and warm (18 ± 2°C) stratification, macromolecular substances containing carbon or nitrogen accumulated, and respiration, antioxidant enzyme activity, and gibberellin (GA3) /abscisic acid (ABA) and auxin (IAA)/ABA ratios increased significantly in seeds. Water absorption also increased as endocarps softened. Thus, physiological dormancy of seed was broken. Although warm and cold stratification increased separation between endocarp and embryo, the endocarp binding force was removed insufficiently, because only 10.20% of seeds germinated. Therefore, stratified seeds were treated with simulated bird digestion. Then, folds and cracks in loosened endocarps increased permeability, and water absorption rate increased to 64.43% compare to 21.14% in cold and warm stratification treatment. With simulated digestion, 24.20% of radicles broke through the endocarp with plumules and cambiums to develop into seedlings. Thus, the seed dormancy type of R. rugosa is physiological as seeds imbibed water and possessed fully developed embryos with a low growth potential in combination with a mechanical constraint from the endocarp. Cold stratification helped remove physiological dormancy, and additional warm stratification accelerated the process. The optimal stratification treatment was 4°C for 45 days followed by 18 ± 2°C for 15 days. After warm and cold stratification, simulated bird digestion broke the mechanical constraint from the seed covering layers. Based on this research, production of R. rugosa seedlings can be greatly increased to help protect the species from further declines.

Project description:Background:Small randomized trials demonstrated that a lower compared with higher dialysate temperature reduced the average drop in intradialytic blood pressure. Some observational studies demonstrated that a lower compared with higher dialysate temperature was associated with a lower risk of all-cause mortality and cardiovascular mortality. There is now the need for a large randomized trial that compares the effect of a low vs high dialysate temperature on major cardiovascular outcomes. Objective:The purpose of this study is to test the effect of outpatient hemodialysis centers randomized to (1) a personalized temperature-reduced dialysate protocol or (2) a standard-temperature dialysate protocol for 4 years on cardiovascular-related death and hospitalizations. Design:The design of the study is a pragmatic, registry-based, open-label, cluster randomized controlled trial. Setting:Hemodialysis centers in Ontario, Canada, were randomized on February 1, 2017, for a trial start date of April 3, 2017, and end date of March 31, 2021. Participants:In total, 84 hemodialysis centers will care for approximately 15 500 patients and provide over 4 million dialysis sessions over a 4-year follow-up. Intervention:Hemodialysis centers were randomized (1:1) to provide (1) a personalized temperature-reduced dialysate protocol or (2) a standard-temperature dialysate protocol of 36.5°C. For the personalized protocol, nurses set the dialysate temperature between 0.5°C and 0.9°C below the patient's predialysis body temperature for each dialysis session, to a minimum dialysate temperature of 35.5°C. Primary outcome:A composite of cardiovascular-related death or major cardiovascular-related hospitalization (a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) captured in Ontario health care administrative databases. Planned primary analysis:The primary analysis will follow an intent-to-treat approach. The hazard ratio of time-to-first event will be estimated from a Cox model. Within-center correlation will be considered using a robust sandwich estimator. Observation time will be censored on the trial end date or when patients die from a noncardiovascular event. Trial Registration:www.clinicaltrials.gov; identifier: NCT02628366.

Dataset Information

Effect of cool vs. warm dialysate on toxin removal: rationale and study design.

Publications

Effect of cool vs. warm dialysate on toxin removal: rationale and study design.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets