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

Area of Science:

• Nephrology
• Cardiovascular Medicine
• Clinical Trials

Background:

• Previous studies suggest lower dialysate temperatures may reduce intradialytic hypotension and mortality.
• A large-scale randomized trial is needed to confirm the effect of dialysate temperature on major cardiovascular outcomes.

Purpose of the Study:

• To evaluate the impact of a personalized, temperature-reduced dialysate protocol versus a standard-temperature protocol on cardiovascular death and hospitalizations in hemodialysis patients.
• To assess the 4-year efficacy of individualized dialysate temperature management in reducing adverse cardiovascular events.

Main Methods:

• Pragmatic, registry-based, open-label, cluster randomized controlled trial involving 84 hemodialysis centers in Ontario, Canada.
• Approximately 15,500 patients will be followed for 4 years, receiving either a personalized reduced dialysate temperature (0.5°C-0.9°C below predialysis temperature, minimum 35.5°C) or a standard 36.5°C protocol.
• The primary outcome is a composite of cardiovascular-related death or major cardiovascular-related hospitalization, analyzed using intent-to-treat and Cox models.

Main Results:

• Data collection occurred from April 2017 to March 2021.
• Over 4 million dialysis sessions were included in the analysis.
• Primary outcome data were captured via Ontario health care administrative databases.

Conclusions:

• The study aims to provide definitive evidence on the role of dialysate temperature in cardiovascular risk management for hemodialysis patients.
• Results will guide clinical practice regarding optimal dialysate temperature settings to improve patient safety and reduce cardiovascular morbidity and mortality.