Dataset Information

Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial.

ABSTRACT:

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.

SUBMITTER: Al-Jaishi AA

PROVIDER: S-EPMC7003172 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial.

Al-Jaishi Ahmed A AA McIntyre Christopher W CW Sontrop Jessica M JM Dixon Stephanie N SN Anderson Sierra S Bagga Amit A Benjamin Derek D Berry David D Blake Peter G PG Chambers Laura L Chan Patricia C K PCK Delbrouck Nicole N Devereaux P J PJ Ferreira-Divino Luis F LF Goluch Richard R Gregor Laura L Grimshaw Jeremy M JM Hanson Garth G Iliescu Eduard E Jain Arsh K AK Lok Charmaine E CE Mustafa Reem A RA Nathoo Bharat B Nesrallah Gihad E GE Oliver Matthew J MJ Pandeya Sanjay S Parmar Malvinder S MS Perkins David D Presseau Justin J Rabin Eli E Sasal Joanna J Shulman Tanya T Sood Manish M MM Steele Andrew A Tam Paul P Tascona Daniel D Wadehra Davinder D Wald Ron R Walsh Michael M Watson Paul P Wodchis Walter W Zager Phillip P Zwarenstein Merrick M Garg Amit X AX

Canadian journal of kidney health and disease 20200205

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

PMID: 32076569

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Project description:BackgroundCool 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/designThis 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.DiscussionThis 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 registrationClinicaltrials.gov Identifier--NCT02064153.

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Dataset Information

Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial.

Background

Objective

Design

Setting

Participants

Intervention

Primary outcome

Planned primary analysis

Trial registration

Publications

Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial.

Similar Datasets

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