Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02628366|
Recruitment Status : Active, not recruiting
First Posted : December 11, 2015
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Kidney Diseases End-Stage Kidney Disease Hemodialysis||Other: Personalized Dialysate Temperature||Not Applicable|
Show Detailed Description
|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: 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|
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.
- Cardiovascular-related mortality [ Time Frame: Four Years ]
- Hospitalization for non-fatal myocardial infarction [ Time Frame: Four Years ]
- Hospitalization for non-fatal ischemic stroke [ Time Frame: Four Years ]
- Hospitalization for non-fatal congestive heart failure [ Time Frame: Four Years ]
- 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.
- 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.
- All-cause mortality [ Time Frame: Four Years ]All-cause mortality
- 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.
- 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.
- 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.
- 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:
- 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.
- At least a 25% relative reduction in nadir systolic blood pressure from pre-dialysis systolic blood pressure or nadir ≤ 90 mmHg.
- At least a 25% relative reduction in nadir systolic blood pressure from pre-dialysis systolic blood pressure.
- A drop in nadir systolic blood pressure by ≥ 35 mmHg from pre-dialysis systolic blood pressure.
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|