Major Outcomes With Personalized Dialysate TEMPerature

Summary

People with failed kidneys need an artificial kidney machine (called dialysis) to remove toxins and extra fluid from the body. Most patients receive dialysis treatments at a hospital three times a week. During treatment, a patient's blood pressure may drop, causing dizziness and muscle cramping. Repeated drops in blood pressure can also injure the heart and brain. Over time, this can lead to heart attacks, strokes, and sometimes death due to cardiovascular causes. New research shows that cooling the temperature of the dialysis fluid (called dialysate) can reduce heart and brain injury. In most hospitals, all patients' dialysate temperature is set at 36.5 ºC (to match body temperature). In a study of 73 patients, we showed that reducing the dialysate temperature by 0.5 ºC below body temperature protected the heart and brain from injury \[1,2\]. We now want to test this simple, safe, low-cost intervention in a large study with \~7500 dialysis patients in Ontario. We can lower the dialysate temperature on dialysis machines in Ontario at no added cost. This intervention has the potential to reduce many hospitalizations and deaths in Ontario, and relieve suffering in patients with kidney failure.

Conditions

• Kidney Diseases
• End-Stage Kidney Disease
• Hemodialysis

Interventions

OTHER

Personalized Dialysate Temperature

Dialysis centres randomized to the intervention will provide temperature-reduced personalized hemodialysis. A nurse will set the temperature of the dialysate to 0.5°C below each patient's body temperature measured just before starting the dialysis treatment. We are aware that some dialysis machines (e.g. Fresenius 5008) are only able to modify dialysate temperature by 0.5°C increments. For centres with those machines, the nurse will set the dialysate temperature 0.5 to 0.9 °C below each patient's body temperature (measured before starting the hemodialysis treatment) to a minimum of 35.5°C.

Sponsors & Collaborators

• Population Health Research Institute

  collaborator OTHER

• Ottawa Hospital Research Institute

  collaborator OTHER

• Dialysis Clinic, Inc.

  collaborator INDUSTRY

• Cancer Care Ontario

  collaborator OTHER

• Institute for Clinical Evaluative Sciences

  collaborator OTHER

• The Kidney Foundation of Canada

  collaborator OTHER

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  lead OTHER

Principal Investigators

• Amit X Garg, PhD · London Health Sciences Centre

• Christopher W McIntyre, MD · London Health Sciences Centre

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-03

Primary Completion

2021-03-31

Completion

2021-03-31

Countries

• Canada

Study Locations