. 2020 Feb 5:7:2054358119887988.

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

Ahmed A Al-Jaishi^{1

2

3}, Christopher W McIntyre^{1

4}, Jessica M Sontrop^{1

4}, Stephanie N Dixon^{1

2

4}, Sierra Anderson¹, Amit Bagga⁵, Derek Benjamin⁶, David Berry⁷, Peter G Blake^{1

4}, Laura Chambers¹, Patricia C K Chan⁸, Nicole Delbrouck⁹, P J Devereaux³, Luis F Ferreira-Divino¹, Richard Goluch¹⁰, Laura Gregor¹¹, Jeremy M Grimshaw^{12

13}, Garth Hanson¹⁴, Eduard Iliescu¹⁵, Arsh K Jain^{1

2

4}, Charmaine E Lok¹⁶, Reem A Mustafa^{3

17}, Bharat Nathoo¹⁸, Gihad E Nesrallah¹⁹, Matthew J Oliver^{20

21}, Sanjay Pandeya²², Malvinder S Parmar²³, David Perkins²⁴, Justin Presseau^{12

13}, Eli Rabin²⁵, Joanna Sasal²⁶, Tanya Shulman²⁷, Manish M Sood^{2

12

13}, Andrew Steele²⁸, Paul Tam²⁹, Daniel Tascona³⁰, Davinder Wadehra³¹, Ron Wald^{2

21

32}, Michael Walsh^{3

33}, Paul Watson³⁴, Walter Wodchis^{2

21}, Phillip Zager³⁵, Merrick Zwarenstein^{2

4}, Amit X Garg^{1

2

3

4}

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

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

Ahmed A Al-Jaishi et al. Can J Kidney Health Dis. 2020.

. 2020 Feb 5:7:2054358119887988.

doi: 10.1177/2054358119887988. eCollection 2020.

Authors

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
in English, French

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.

Contexte: De petits essais à répartition aléatoire ont montré que l’utilisation d’un dialysat à basse température réduisait le risque d’hypotension intra-dialytique. De même, certaines études observationnelles ont démontré qu’un dialysat à basse température était associé à un plus faible risque de mortalité toute cause ou d’origine cardiovasculaire. Le temps est venu de procéder à un vaste essai à répartition aléatoire comparant les effets d’un dialysat à basse température et à température standard sur les principaux résultats cardiovasculaires.

Objectif: Répartir aléatoirement des centres d’hémodialyse ambulatoire pour qu’ils suivent pendant quatre ans (i) un protocole personnalisé de dialysat à basse température ou (ii) un protocole de dialysat à température standard, et tester l’effet sur les hospitalisations et la mortalité attribuables à des événements cardiovasculaires.

Type d’étude: Un essai clinique à répartition aléatoire en grappes.

Cadre: Le 1er février 2017, des centres d’hémodialyse de l’Ontario (Canada) ont été répartis aléatoirement en vue d’un essai qui a débuté le 3 avril 2017 et qui se poursuivra jusqu’au 31 mars 2021.

Participants: Quatre-vingt-quatre centres d’hémodialyse qui prendront en charge environ 15 500 patients pendant les quatre ans de suivi.

Intervention: Les centres d’hémodialyse ont été répartis aléatoirement (1:1) pour offrir (i) un protocole personnalisé de dialysat à température réduite ou (ii) un protocole de dialysat à 36,5°C. Pour le protocole personnalisé, les infirmières règlent la température du dialysat entre 0,5 et 0,9°C sous la température corporelle du patient mesurée avant la dialyse, jusqu’à une température minimale de 35,5°C.

Principaux résultats: Un ensemble d’hospitalisations attribuables à un événement cardiovasculaire majeur (accident ischémique cérébral non fatal, infarctus du myocarde ou insuffisance cardiaque congestive) et de décès d’origine cardiovasculaire consignés dans les bases de données de santé de l’Ontario.

Principale analyse envisagée: L’analyse primaire adoptera une approche fondée sur l’intention de traiter. Un modèle de Cox servira à estimer le rapport de risque du temps écoulé jusqu’au premier événement. La corrélation intra-centre sera prise en compte à l’aide d’un estimateur sandwich robuste. Le temps d’observation sera censuré à la date de fin de l’essai ou au moment d’un décès non lié à un événement cardiovasculaire.

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

PubMed Disclaimer

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 Medical Director for Dialysis Clinic Inc, which provided partial funding for Major Outcomes with Personalized Dialysate TEMPerature (MyTEMP). Dr Wald has received unrestricted research support from Baxter Healthcare. The remaining authors declare they have no other relevant interests.

Figures

**Figure 1.**
Precis-2 wheel highlighting the pragmatism of MyTEMP trial for 9 domains. *Note.* Small reductions in pragmatism relate to (1) monthly data collection from centers to assess intervention adherence and (2) contact with centers that had less than 80% adherence. MyTEMP = Major Outcomes with Personalized Dialysate TEMPerature.

**Figure 2.**
Map of Ontario, Canada, depicting participating centers across the province. *Note.* Each black dot represents one of the 84 participating hemodialysis centers that in total care for approximately 7500 patients at any time. During the 4-year trial period, these 84 centers will care for approximately 15 550 patients and will provide over 4 million hemodialysis sessions.

See this image and copyright information in PMC

References

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1. Canadian Institutes for Health Information. CORR annual statistics 2019. Date unknown. https://www.cihi.ca/en/organ-replacement-in-canada-corr-annual-statistic.... Accessed January 29, 2020.
1. Foley RN, Collins AJ. End-stage renal disease in the United States: an update from the United States Renal Data System. J Am Soc Nephrol. 2007;18(10):2644-2648. doi: 10.1681/ASN.2007020220. - DOI - PubMed
1. Foote C, Ninomiya T, Gallagher M, et al. Survival of elderly dialysis patients is predicted by both patient and practice characteristics. Nephrol Dial Transplant. 2012;27(9):3581-3587. doi: 10.1093/ndt/gfs096. - DOI - PubMed
1. Jassal S, Trpeski L, Zhu NSF, Fenton S, Hemmelgarn B. Changes in survival among elderly patients initiating dialysis from 1990 to 1999. CMAJ. 2007;177(9):1033-1038. doi: 10.1503/cmaj.061765. - DOI - PMC - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract
in English, French

Conflict of interest statement

Figures

References

Associated data

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous

Abstract in English, French

Conflict of interest statement

Figures

References

Associated data

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous

Abstract
in English, French