Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial
Authors: Al-Jaishi Ahmed A. , McIntyre Christopher W. , Sontrop Jessica M. , Dixon Stephanie N. , Anderson Sierra , Bagga Amit , Benjamin Derek , Berry David , Blake Peter G. , Chambers Laura , Chan Patricia C. K. , Delbrouck Nicole , Devereaux P. J. , Ferreira-Divino Luis F. , Goluch Richard , Gregor Laura , Grimshaw Jeremy M. , Hanson Garth , Iliescu Eduard , Jain Arsh K. , Lok Charmaine E. , Mustafa Reem A. , Nathoo Bharat , Nesrallah Gihad E. , Oliver Matthew J. , Pandeya Sanjay , Parmar Malvinder S. , Perkins David , Presseau Justin , Rabin Eli , Sasal Joanna , Shulman Tanya , Sood Manish M. , Steele Andrew , Tam Paul , Tascona Daniel , Wadehra Davinder , Wald Ron , Walsh Michael , Watson Paul , Wodchis Walter , Zager Phillip , Zwarenstein Merrick , Garg Amit X. 
Published: February 2020

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.