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

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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.

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 CK
  • Delbrouck, Nicole
  • Devereaux, Philip
  • Ferreira-Divino, Luis F
  • Goluch, Richard
  • Gregor, Laura
  • Grimshaw, Jeremy M
  • Hanson, Garth
  • Iliescu, Eduard
  • Jain, Arsh K
  • Lok, Charmaine
  • Mustafa, Reem Adel
  • Nathoo, Bharat
  • Nesrallah, Gihad E
  • Oliver, Matthew J
  • Pandeya, Sanjay
  • Parmar, Malvinder S
  • Perkins, David
  • Presseau, Justin
  • Rabin, Elijah
  • 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

publication date

  • January 2020