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Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP)

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ClinicalTrials.gov Identifier: NCT02628366
Recruitment Status : Active, not recruiting
First Posted : December 11, 2015
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Population Health Research Institute
Ottawa Hospital Research Institute
Dialysis Clinic, Inc.
Cancer Care Ontario
Institute for Clinical Evaluative Sciences
The Kidney Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Kidney Diseases End-Stage Kidney Disease Hemodialysis Other: Personalized Dialysate Temperature Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Major Outcomes With Personalized Dialysate TEMPerature: Cluster Randomized Controlled Trial
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Personalized Dialysate Temperature
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
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.
Other Name: Individualized Dialysate Temperature

No Intervention: Fixed Dialysate Temperature at 36.5°C
Dialysis centres in the control group will provide usual care, which is standard dialysis using a fixed dialysate temperature of 36.5°C



Primary Outcome Measures :
  1. Composite outcome of cardiovascular-related mortality or major cardiovascular event [ Time Frame: Four Years ]

    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.



Secondary Outcome Measures :
  1. Cardiovascular-related mortality [ Time Frame: Four Years ]
  2. Hospitalization for non-fatal myocardial infarction [ Time Frame: Four Years ]
  3. Hospitalization for non-fatal ischemic stroke [ Time Frame: Four Years ]
  4. Hospitalization for non-fatal congestive heart failure [ Time Frame: Four Years ]
  5. Composite outcome of all-cause mortality or major cardiovascular event [ Time Frame: Four Years ]
    Composite of all-cause mortality and hospitalization for a major cardiovascular event including: myocardial infarction, ischemic stroke, or congestive heart failure.

  6. Hemodialysis sessions complicated by intradialytic hypotension [ Time Frame: Four Years ]
    We will define intradialytic hypotension if a patient experiences any of the following: i) nadir systolic blood pressure < 90 mmHg anytime during the hemodialysis session (regardless if patients begin the hemodialysis session with systolic blood pressure below 90 mmHg); or ii) drop in systolic blood pressure by ≥ 30 mmHg from the pre-dialysis systolic blood pressure reading.

  7. All-cause mortality [ Time Frame: Four Years ]
    All-cause mortality


Other Outcome Measures:
  1. Lower extremity amputations [ Time Frame: Four Years ]
    Patients on hemodialysis, especially those with diabetes, have a high incident rate of amputation. Amputations are associated with cardiovascular risk factors and likely linked to vascular injury caused by hemodialysis-induced ischemia, which complicates pre-existing arterial disease and diabetes related injury. We will compare the lower extremity amputation (excluding digit amputations) rate for the two groups. In separate analyses, we will estimate the amputation rate for subgroups of patients with diabetes, as well as those with and without a history of lower extremity amputation in the 10 years before the trial start date or the date entering the trial cohort for new patients starting MyTEMP after April 3rd, 2017.

  2. Major falls and fractures [ Time Frame: Four Years ]
    Many patients on dialysis are frail and prone to falling, which may also predispose them to suffer a fracture. Bone fractures are an important outcome and can result in morbidity, high economic costs, and mortality. Intra-dialytic hypotension might increase the rate and severity of falls after a hemodialysis session leading to additional fractures requiring hospitalizations. We will estimate the rate of fractures for both arms of the trial.

  3. All-Cause emergency department visits or hospitalizations (analyzed separately and as a composite) [ Time Frame: Four Years ]
    Patients on hemodialysis are frequently hospitalized and account for 5% to 7% of healthcare expenditures in developed countries despite comprising a very small percentage of the general adult population. These patients have several characteristics that make them vulnerable to hospitalization and emergency department use, including multimorbidity, high rates cardiovascular and complications, and complex medication regimens. The historic hazard rate for emergency department visits was 1.05, all-cause hospitalization was 0.65, and the composite all-cause emergency department visits or hospitalizations over a 4-year period (from April 1, 2013 to March 31, 2017) for an open cohort was 1.22 events per person-year.

  4. Alternative definitions of intradialytic hypotension [ Time Frame: Four Years ]

    In addition to the definition stated above, we will also consider alternate definitions of intradialytic hypotension:

    1. Systolic blood pressure < 90 mmHg alone. A nadir systolic blood pressure of < 90 mmHg was strongly associated with all-cause mortality in a previous observational study.
    2. At least a 25% relative reduction in nadir systolic blood pressure from pre-dialysis systolic blood pressure or nadir ≤ 90 mmHg.
    3. At least a 25% relative reduction in nadir systolic blood pressure from pre-dialysis systolic blood pressure.
    4. A drop in nadir systolic blood pressure by ≥ 35 mmHg from pre-dialysis systolic blood pressure.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

This pragmatic cluster randomized controlled trial has only two inclusion criteria:

Inclusion Criteria:

  • The medical director of the dialysis centre must provide informed consent and be willing to transition their patients to receive temperature-reduced personalized hemodialysis (if randomized to the intervention) or stay with the standard 36.5°C hemodialysis temperature during the course of the trial (if randomized to the control group); and
  • The centre must care for a minimum of 15 patients being treated with conventional in-centre hemodialysis.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628366


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5W9
Sponsors and Collaborators
Lawson Health Research Institute
Population Health Research Institute
Ottawa Hospital Research Institute
Dialysis Clinic, Inc.
Cancer Care Ontario
Institute for Clinical Evaluative Sciences
The Kidney Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Amit X Garg, PhD London Health Sciences Centre
Principal Investigator: Christopher W McIntyre, MD London Health Sciences Centre

Publications:
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02628366     History of Changes
Other Study ID Numbers: R-15-302
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawson Health Research Institute:
Cluster randomized Controlled Trial
Personalized Dialysate Temperature
Cooler Dialysate Temperature
Mortality
Cardiovascular Events
Myocardial Infarction
Ischemic Stroke
Congestive Heart Failure
Dialysis Solutions
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Dialysis Solutions
Pharmaceutical Solutions