Major outcomes with personalized dialysate TEMPerature (MyTEMP): rationale and design of a pragmatic, registry-based, cluster randomized controlled trial
Al-Jaishi AA, McIntyre CW, Sontrop JM, Dixon SN, Anderson S, Bagga A, Benjamin D, Berry D, Blake PG, Chambers L, Chan PCK, Delbrouck N, Devereaux PJ, Ferreira-Divino LF, Goluch R, Gregor L, Grimshaw JM, Hanson G, Iliescu E, Jain AK, Lok CE, Mustafa RA, Nathoo B, Nesrallah GE, Oliver MJ, Pandeya S, Parmar M, Perkins D, Presseau J, Rabin E, Sasal J, Shulman T, Sood MM, Steele A, Tam P, Tascona D, Wadehra D, Wald R, Walsh M, Watson P, Wodchis W, Zager P, Zwarenstein M, Garg AX. Can J Kidney Health Dis. 2020; 7:1-18. Epub 2020 Feb 5. DOI: https://doi.org/10.1177/2054358119887988
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.
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