Effect of Cooler Dialysate Temperature on Haemodynamic Stability in Hypotensive Patients on Maintenance Haemodialysis

The aim of this study is to investigate the effect of using a cooler dialysate temperature (35.5°C) on hemodynamic stability in hypotensive patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis, compared to the standard dialysate temperature (37°C). Hemodialysis is a critical life-saving procedure, but complications such as intradialytic hypotension can lead to session interruptions and increased morbidity and mortality. This study is the first, to our knowledge, to specifically examine the benefits of cooler dialysate in a hypotensive ESRD population, with the goal of improving hemodynamic stability during dialysis sessions.

Parallel group, double blind, randomised controlled trial

Conducted in a tertiary care hospital, the study ensures blinding of participants, healthcare providers, data collectors, and outcome assessors through concealed temperature settings. The design aims to minimize bias and assess the impact of cooler dialysate on intradialytic hypotension

Patients from both genders between 18 and 60 years old who were on twice weekly HD and had hypotension were included. Patients with thyroid disease, anaemia, and taking anti-hypertensive medications were excluded.

Cooler dialysate temperature (35.5°C) on hemodynamic stability in hypotensive patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis, compared to the standard dialysate temperature (37°C).

This double-blind, randomized trial assesses the impact of cooler dialysate (35.5°C) versus standard dialysate (37°C) on hemodynamic stability in hypotensive ESRD patients during hemodialysis.

Random allocation in this study is achieved using a computer-generated randomization sequence, prepared by an independent statistician who is not involved in the trial's conduct. Participants are assigned to either the cooler dialysate (35.5°C) or standard dialysate (37°C) group in a 1:1 ratio, with allocation concealed using sealed, opaque envelopes. These envelopes are opened only after participant enrollment by an independent technician, who then programs the dialysis machines accordingly, ensuring that neither participants nor healthcare providers can influence or predict group assignment. This method ensures a robust and unbiased randomization process.

This study is a double-blind randomized controlled trial investigating the effect of cooler dialysate temperature on hemodynamic stability in hypotensive patients undergoing maintenance hemodialysis. Both participants and healthcare providers, including physicians and nurses, are blinded to the dialysate temperature settings. The dialysis machines are pre-programmed by an independent technician, and the temperature display is concealed to prevent unblinding. Data collectors and outcome assessors are also blinded to group allocations, analyzing anonymized data without knowledge of the intervention. The principal investigator remains blinded during data collection and analysis to minimize bias. Additionally, the Data Safety and Monitoring Board (DSMB) reviews coded, anonymized data to ensure safety and efficacy without compromising blinding. This double-blind design ensures the integrity and reliability of the study outcomes.

Effect of Cooler Dialysate Temperature on Haemodynamic Stability in Hypotensive Patients on Maintenance Haemodialysis

Mar 25

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