Major Outcomes With Personalized Dialysate TEMPerature

NCT02628366 | Completed DMC

• 1 other identifier: R-15-302
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cluster randomized Controlled Trial; Personalized Dialysate Temperature; Cooler Dialysate Temperature; Mortality; Cardiovascular Events; Myocardial Infarction; Ischemic Stroke; Congestive Heart Failure; Dialysis Solutions

Outcome Measures

Primary Outcomes (1)

• Composite outcome of cardiovascular-related mortality or major cardiovascular event

  There are many challenges associated with selecting the primary endpoint in MyTEMP because of heterogeneity of the population, complexity of renal pathophysiology and its interaction with cardiovascular disease, and competing risks of non-cardiovascular-related death. Our primary outcome is a composite outcome of cardiovascular-related mortality or a hospitalization for non-fatal major cardiovascular event which is any of myocardial infarction, ischemic stroke, or congestive heart failure. We chose a cause-specific death (i.e. cardiovascular) in our endpoint, in contrast to all-cause mortality, because non-cardiovascular causes of death are common in the hemodialysis population and the intervention is less likely to reduce the rate of such deaths. However, as a secondary outcome (see Secondary outcomes), we will also test the effect of personalized temperature-reduced dialysate temperature on all-cause mortality.

  Four Years

Secondary Outcomes (7)

• Key secondary outcome: Between-group mean difference in the intradialytic drop of systolic blood pressure.

  Four Years

• Composite outcome of all-cause mortality or major cardiovascular event

  Four Years

• All-cause mortality

  Four Years

• Hospitalization for non-fatal myocardial infarction

  Four Years

• Hospitalization for non-fatal congestive heart failure

  Four Years

Other Outcomes (10)

• Composite of All-Cause emergency department visits or all-cause hospitalizations (repeated measure)

  Four Years

• All-Cause emergency department visits (repeated measures)

  Four Years

• All-cause hospitalizations (repeated measure)

  Four years

Study Arms (2)

Personalized Dialysate Temperature

EXPERIMENTAL

Dialysis centres randomized to the intervention arm 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.

Other: Personalized Dialysate Temperature

Fixed Dialysate Temperature at 36.5°C

NO INTERVENTION

Dialysis centres in the control group will provide usual care, which is standard dialysis using a fixed dialysate temperature of 36.5°C

Interventions

Personalized Dialysate Temperature OTHER

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.

Also known as: Individualized Dialysate Temperature

Personalized Dialysate Temperature

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The hemodialysis centre must have cared for a minimum of 15 outpatients being treated with maintenance in-centre hemodialysis on January 1st, 2017.
• The medical director of the hemodialysis centre (who acted as the centre's gatekeeper) must have been willing for their centre to adopt the randomly allocated dialysate temperature protocol for the duration of the trial.

You may not qualify if:

• The centre cares for less than 15 patients being treated with conventional in-centre hemodialysis.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Population Health Research Institute: collaborator
• Ottawa Hospital Research Institute: collaborator
• Dialysis Clinic, Inc.: collaborator
• Cancer Care Ontario: collaborator
• Institute for Clinical Evaluative Sciences: collaborator
• The Kidney Foundation of Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Related Publications (5)

• Presseau J, Mutsaers B, Al-Jaishi AA, Squires J, McIntyre CW, Garg AX, Sood MM, Grimshaw JM; Major outcomes with personalized dialysate TEMPerature (MyTEMP) investigators. Barriers and facilitators to healthcare professional behaviour change in clinical trials using the Theoretical Domains Framework: a case study of a trial of individualized temperature-reduced haemodialysis. Trials. 2017 May 22;18(1):227. doi: 10.1186/s13063-017-1965-9.

  PMID: 28532509 BACKGROUND

• Ward JM, Getchell L, Garg AX; MyTEMP Investigators. Patient and caregiver involvement in a multicentre clustered hemodialysis trial. CMAJ. 2018 Nov 7;190(Suppl):S32-S33. doi: 10.1503/cmaj.180403. No abstract available.

  PMID: 30404848 BACKGROUND

• MyTEMP writing committee. Personalised cooler dialysate for patients receiving maintenance haemodialysis (MyTEMP): a pragmatic, cluster-randomised trial. Lancet. 2022 Nov 12;400(10364):1693-1703. doi: 10.1016/S0140-6736(22)01805-0. Epub 2022 Nov 4.

  PMID: 36343653 DERIVED

• Dixon SN, Sontrop JM, Al-Jaishi A, Killin L, McIntyre CW, Anderson S, Bagga A, Benjamin D, Blake P, Devereaux PJ, Iliescu E, Jain A, Lok CE, Nesrallah G, Oliver MJ, Pandeya S, Sood MM, Tam P, Wald R, Walsh M, Zwarenstein M, Garg AX. MyTEMP: Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial. Can J Kidney Health Dis. 2021 Aug 27;8:20543581211041182. doi: 10.1177/20543581211041182. eCollection 2021.

  PMID: 34471542 DERIVED

• Al-Jaishi AA, McIntyre CW, Sontrop JM, Dixon SN, Anderson S, Bagga A, Benjamin D, Berry D, Blake PG, Chambers L, Chan PCK, Delbrouck N, Devereaux PJ, Ferreira-Divino LF, Goluch R, Gregor L, Grimshaw JM, Hanson G, Iliescu E, Jain AK, Lok CE, Mustafa RA, Nathoo B, Nesrallah GE, Oliver MJ, Pandeya S, Parmar MS, Perkins D, Presseau J, Rabin E, Sasal J, Shulman T, Sood MM, Steele A, Tam P, Tascona D, Wadehra D, Wald R, Walsh M, Watson P, Wodchis W, Zager P, Zwarenstein M, Garg AX. Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial. Can J Kidney Health Dis. 2020 Feb 5;7:2054358119887988. doi: 10.1177/2054358119887988. eCollection 2020.

  PMID: 32076569 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic; Myocardial Infarction; Ischemic Stroke; Heart Failure

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Amit X Garg, PhD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Christopher W McIntyre, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: December 11, 2015
• Study Start: April 3, 2017
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)