ArticleCanadian journal of kidney health and disease2020
Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial.
Article in Canadian journal of kidney health and disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02628366 (Major Outcomes With Personalized Dialysate TEMPerature), which is not on this map. Cited by 18 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Major Outcomes With Personalized Dialysate TEMPerature: Pragmatic, Registry-Based, Cluster Randomized Controlled Trial
Who cites it
18 citing papers in PubMed, 31 citations in OpenAlex.
- BioImpedance Spectroscopy to maintain Renal Output: the BISTRO randomised controlled trial.Health technology assessment (Winchester, England) · 2025Trial
- Centre-level fluid management practices in the BISTRO trial and their lack of association with participant fluid status and blood pressure in non-anuric haemodialysis patients.BMC nephrology · 2024Trial
- Statistical analysis of Likert-based ordinal scales: a guide for clinical trialists.BMC medical research methodology · 2026Article
- Navigating the consent river: questions to consider before waiving consent requirements in pragmatic cluster randomised trials.Journal of medical ethics · 2025Article
- Article
- Dialysis and cognitive impairment.Nature reviews. Nephrology · 2025Review
- Bayesian Analysis of Time-To-Event Data in a Cluster-Randomized Trial: Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP) Trial.Canadian journal of kidney health and disease · 2025Article
- Cultivating Innovative, Pragmatic, Randomized Controlled Registry Trials Embedded in Hemodialysis Care: Conference Proceeding From Gardener's Grove 2023.Canadian journal of kidney health and disease · 2025Article
- Use cases of registry-based randomized controlled trials-A review of the registries' contributions and constraints.Clinical and translational science · 2024Review
- Article
- Health Services Use and Outcomes for Hospital Admissions With a Major Cardiovascular Event Recorded in Health Care Administrative Data in Patients Receiving Maintenance Hemodialysis: A Retrospective Cohort Study.Canadian journal of kidney health and disease · 2023Article
- Cardiovascular Safety of Metoclopramide Compared to Domperidone: A Population-Based Cohort Study.Journal of the Canadian Association of Gastroenterology · 2021Article
- Article
- Therapeutic Hypothermia Reduces Peritoneal Dialysis Induced Myocardial Blood Flow Heterogeneity and Arrhythmia.Frontiers in medicine · 2021Article
- MyTEMP: Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial.Canadian journal of kidney health and disease · 2021Article
- "Is It Removed During Dialysis?"-Cognitive Dysfunction in Advanced Kidney Failure-A Review Article.Frontiers in neurology · 2021Review
- A Review on the Application and Limitations of Administrative Health Care Data for the Study of Acute Kidney Injury Epidemiology and Outcomes in Children.Frontiers in pediatrics · 2021Review
- Cultivating Innovative Pragmatic Cluster-Randomized Registry Trials Embedded in Hemodialysis Care: Workshop Proceedings From 2018.Canadian journal of kidney health and disease · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
44 authors at 20 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSmall 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.
objectiveThe 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.
designThe design of the study is a pragmatic, registry-based, open-label, cluster randomized controlled trial.
settingHemodialysis 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.
participantsIn total, 84 hemodialysis centers will care for approximately 15 500 patients and provide over 4 million dialysis sessions over a 4-year follow-up.
interventionHemodialysis 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 registrationwww.clinicaltrials.gov; identifier: NCT02628366.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.