MyTEMP: Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial

Area of Science:

• Nephrology and Cardiovascular Health
• Clinical Trial Design and Analysis
• Dialysis and Patient Outcomes

Background:

• The Major Outcomes with Personalized Dialysate TEMPerature (MyTEMP) trial is a 4-year cluster-randomized clinical trial.
• It compares a personalized, temperature-reduced dialysate protocol against a standard 36.5°C dialysate temperature.
• The study aims to assess the impact on cardiovascular-related death and hospitalization in hemodialysis patients.

Purpose of the Study:

• To outline the statistical analysis plan for the MyTEMP clinical trial.
• To detail the methodology for analyzing primary and secondary outcomes.
• To ensure a robust and transparent evaluation of the personalized dialysate temperature intervention.

Main Methods:

• A pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized trial involving 84 dialysis centers in Ontario, Canada.
• Approximately 13,500 patients receiving in-center hemodialysis were included.
• Data were primarily sourced from administrative health care databases; covariate-constrained randomization allocated centers to intervention or control groups.

Main Results:

• The primary outcome is a composite of cardiovascular-related death or major cardiovascular-related hospitalization.
• A key secondary outcome is the mean drop in intradialytic systolic blood pressure.
• The primary analysis uses an intent-to-treat approach with a subdistribution hazards model, accounting for within-center correlation.

Conclusions:

• The statistical analysis plan provides a framework for evaluating the MyTEMP trial's effectiveness.
• The study design and analysis methods aim to provide reliable insights into personalized dialysate temperature's impact.
• Results are anticipated by 2023, contributing to evidence-based dialysis practices.