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Al-Jaishi AA, McIntyre CW, Sontrop JM, et al. Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial. Can J Kidney Health Dis. 2020;7:2054358119887988doi: 10.1177/2054358119887988.
Al-Jaishi, A. A., McIntyre, C. W., Sontrop, J. M., Dixon, S. N., Anderson, S., Bagga, A., Benjamin, D., Berry, D., Blake, P. G., Chambers, L., Chan, P. C. K., Delbrouck, N., Devereaux, P. J., Ferreira-Divino, L. F., Goluch, R., Gregor, L., Grimshaw, J. M., Hanson, G., Iliescu, E., Jain, A. K., Lok, C. E., Mustafa, R. A., Nathoo, B., Nesrallah, G. E., Oliver, M. J., Pandeya, S., Parmar, M. S., Perkins, D., Presseau, J., Rabin, E., Sasal, J., Shulman, T., Sood, M. M., Steele, A., Tam, P., Tascona, D., Wadehra, D., Wald, R., Walsh, M., Watson, P., Wodchis, W., Zager, P., Zwarenstein, M., & Garg, A. X. (2020). Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial. Canadian journal of kidney health and disease, 72054358119887988. https://doi.org/10.1177/2054358119887988
Al-Jaishi, Ahmed A, et al. "Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial." Canadian journal of kidney health and disease vol. 7 (2020): 2054358119887988. doi: https://doi.org/10.1177/2054358119887988
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 MS, 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. Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial. Can J Kidney Health Dis. 2020 Feb 05;7:2054358119887988. doi: 10.1177/2054358119887988. eCollection 2020. PMID: 32076569; PMCID: PMC7003172.
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Can J Kidney Health Dis. 2020 Feb 05;7:2054358119887988. doi: 10.1177/2054358119887988. eCollection 2020.

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

Canadian journal of kidney health and disease

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

Affiliations

  1. London Health Sciences Centre, ON, Canada.
  2. ICES, ON, Canada.
  3. McMaster University, Hamilton, ON, Canada.
  4. Western University, London, ON, Canada.
  5. Windsor Regional Hospital, ON, Canada.
  6. Royal Victoria Hospital, Barrie, ON, Canada.
  7. Sault Area Hospital, Sault Ste. Marie, ON, Canada.
  8. Michael Garron Hospital, Toronto, ON, Canada.
  9. Renfrew Victoria Hospital, ON, Canada.
  10. Health Sciences North, Sudbury, ON, Canada.
  11. Grand River Hospital, Kitchener, ON, Canada.
  12. Ottawa Hospital Research Institute, ON, Canada.
  13. University of Ottawa, ON, Canada.
  14. Peterborough Regional Health Centre, ON, Canada.
  15. Kingston Health Sciences Centre, ON, Canada.
  16. University Health Network, Toronto, ON, Canada.
  17. University of Kansas Medical Center, Kansas City, USA.
  18. Mackenzie Health, Richmond Hill, ON, Canada.
  19. Humber River Regional Hospital, Toronto, ON, Canada.
  20. Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
  21. University of Toronto, ON, Canada.
  22. Halton Healthcare, Oakville, ON, Canada.
  23. Timmins and District Hospital, ON, Canada.
  24. Trillium Health Partners, Mississauga, ON, Canada.
  25. Niagara Health System, St. Catharines, ON, Canada.
  26. St. Joseph's Health Centre, Toronto, ON, Canada.
  27. North Bay Regional Health Centre, ON, Canada.
  28. Lakeridge Health Corporation, Oshawa, ON, Canada.
  29. Scarborough Health Network, ON, Canada.
  30. Orillia Soldiers' Memorial Hospital, ON, Canada.
  31. William Osler Health Centre, Brampton, ON, Canada.
  32. St. Michael's Hospital, Toronto, ON, Canada.
  33. St. Joseph's Healthcare, Hamilton, ON, Canada.
  34. Thunder Bay Regional Health Sciences Centre, ON, Canada.
  35. Dialysis Clinic Inc, Nashville, TN, USA.

PMID: 32076569 PMCID: PMC7003172 DOI: 10.1177/2054358119887988

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.

© The Author(s) 2020.

Keywords: cardiovascular events; cluster randomized controlled trial; dialysis; dialysis solutions; mortality; personalized dialysate temperature; pragmatic trial

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Zager is the

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