Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP)
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|ClinicalTrials.gov Identifier: NCT02628366|
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : October 5, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Kidney Diseases End-Stage Kidney Disease Hemodialysis||Other: Personalized Dialysate Temperature||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Major Outcomes With Personalized Dialysate TEMPerature: Pragmatic, Registry-Based, Cluster Randomized Controlled Trial|
|Actual Study Start Date :||April 3, 2017|
|Actual Primary Completion Date :||March 31, 2021|
|Actual Study Completion Date :||March 31, 2021|
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
- 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.
- Key secondary outcome: Between-group mean difference in the intradialytic drop of systolic blood pressure. [ Time Frame: Four Years ]A blood pressure drop is defined as the pre-dialysis systolic blood pressure minus the intradialytic nadir systolic blood pressure, where the greater the number (in the positive direction) the larger the drop.
- 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.
- All-cause mortality [ Time Frame: Four Years ]
- Hospitalization for non-fatal myocardial infarction [ Time Frame: Four Years ]
- Hospitalization for non-fatal congestive heart failure [ Time Frame: Four Years ]
- Hospitalization for non-fatal ischemic stroke [ Time Frame: Four Years ]
- Cardiovascular-related mortality [ Time Frame: Four Years ]
- Composite of All-Cause emergency department visits or all-cause hospitalizations (repeated measure) [ 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.
- All-Cause emergency department visits (repeated measures) [ Time Frame: Four Years ]
- All-cause hospitalizations (repeated measure) [ Time Frame: Four years ]
- Hospital encounter with lower limb amputation [ 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.
- Hospital encounter with a major fall or fracture [ 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.
- Intradialytic hypotension [ Time Frame: Four years ]Nadir systolic blood pressure < 90 mmHg anytime during dialysis session when value prior to session was ≥ 90 mmHg, or ii) drop in systolic blood pressure ≥ 30 mmHg anytime during session from value prior to session.
- Intradialytic hypotension alternate definition #1 [ Time Frame: Four years ]Systolic blood pressure < 90 mmHg alone (only count if systolic blood pressure is ≥90 mmHg pre-dialysis).
- Intradialytic hypotension alternate definition #2 [ Time Frame: Four years ]At least a 25% relative reduction in nadir systolic blood pressure from pre-dialysis systolic blood pressure or nadir <90 mmHg (only count latter if not present pre-dialysis).
- Intradialytic hypotension alternate definition #3 [ Time Frame: Four years ]At least a 25% relative reduction in nadir systolic blood pressure from pre-dialysis systolic blood pressure.
- Intradialytic hypotension alternate definition #4 [ Time Frame: Four years ]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|
This pragmatic cluster randomized controlled trial has only two inclusion criteria:
- 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.
- The centre cares for less than 15 patients being treated with conventional in-centre hemodialysis.
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
|London Health Sciences Centre|
|London, Ontario, Canada, N6A5W9|
|Principal Investigator:||Amit X Garg, PhD||London Health Sciences Centre|
|Principal Investigator:||Christopher W McIntyre, MD||London Health Sciences Centre|
Documents provided by Lawson Health Research Institute:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Lawson Health Research Institute|
|Other Study ID Numbers:||
|First Posted:||December 11, 2015 Key Record Dates|
|Last Update Posted:||October 5, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||While data sharing agreements prohibit ICES from making the data publicly available, access may be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS. The full dataset creation plan and underlying analytic code are available from the authors upon request, understanding that the programs may rely upon coding templates or macros that are unique to ICES.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Cluster randomized Controlled Trial
Personalized Dialysate Temperature
Cooler Dialysate Temperature
Congestive Heart Failure
Kidney Failure, Chronic
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Renal Insufficiency, Chronic