Continuous Renal Replacement Therapy for Acute Kidney Injury by Cooling Blood
Study Details
Study Description
Brief Summary
Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and is associated with longer hospital stays and worse survival. The mortality rate of critically ill patients in the ICU who receive renal replacement therapy for AKI ranges between 50-80%, cardiovascular disease being the second largest cause of death. A previous pilot study from the investigator's group showed that myocardial stunning occurs in AKI patients during continuous renal replacement therapy (CRRT) and may explain the high cardiovascular mortality in this population. In the chronic intermittent dialysis setting, mild dialysate cooling was shown to improve intradialytic hemodynamic stability and prevent myocardial stunning. The aim of this study is to find out whether cooling the blood in the CRRT circuit is an effective intervention to prevent myocardial stunning in AKI patients undergoing CRRT and improve patient outcomes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a single center, prospective, randomized, open label, controlled trial comparing standard-of-care temperature management with blood cooling CRRT. We will recruit approximately 140 patients (70 in each group) from the Medical Surgical Intensive Care Unit at University Hospital and The Critical Care Trauma Center at Victoria Hospital in London, Ontario.
The study team will randomize patients with acute kidney injury requiring continuous dialysis therapy into one of two groups; either to standard of care continuous dialysis therapy or to cool blood continuous dialysis therapy. All therapy will be delivered using the Baxter PrisMaxTM CRRT machine with TherMaxTM blood warmer.
All participants will undergo a series of echocardiograms (ultrasound of your heart) prior to continuous dialysis therapy initiation, 4-12 hours into therapy, for up to 7 days after therapy initiation, and at discharge from the intensive care unit. Blood work will be collected at 4 time points, prior to continuous dialysis therapy initiation, 4-12 hours into therapy, 24 hours into therapy, and at ICU discharge.
Hourly nasopharyngeal and skin temperatures will be collected. Oral temperature will be collected every four hours.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control: Standard of care Participants in the control group will receive standard-of-care CRRT prescriptions, and have the returning venous blood warmed with an external blood warmer to a temperature of 37°C. The blood warmer temperature will be adjusted by the CRRT nurse as per usual practice to maintain normothermia. |
|
| Experimental: Intervention: Cooling Participants in the intervention group will receive standard of care CRRT prescriptions and have the blood warmer set to 35.5°C, as long as the nasopharyngeal temperature remains above 35.5°C. |
Procedure: Dialysis cooling
Cooling the blood in the CRRT circuit during delivery
|
Outcome Measures
Primary Outcome Measures
- Regional Wall Motion Abnormalities [At the end of delivery of cool blood during continuous dialysis; 12 to 24 hours]
Number of segments undergoing a 20% reduction in longitudinal systolic strain
Secondary Outcome Measures
- Regional Wall Motion Abnormalities at 7 days [Seven days after the start of cool blood delivery during continuous dialysis]
Number of segments undergoing a 20% reduction in longitudinal systolic strain after delivery of cool blood during continuous dialysis
- Regional Wall Motion Abnormalities at ICU discharge [At ICU discharge, an average of 60 days after the start of cool blood delivery during continuous dialysis]
Number of segments undergoing a 20% reduction in longitudinal systolic strain at ICU discharge
- Duration of Continuous Renal Replacement Therapy (CRRT) [Through study completion, an average of 60 days]
Number of hours of CRRT therapy during ICU admission
- Renal Recovery at 7 days after cool blood continuous dialysis requiring acute kidney injury [Seven days after the start of cool blood delivery during continuous dialysis]
Renal recovery may best be defined as a reduction in AKI stage at seven days after the start of cool blood continuous dialysis treatment determined by creatinine level and urine output.
- Renal Recovery at 24 hours after cool blood continuous dialysis requiring acute kidney injury [24 hours after the start of cool blood delivery during continuous dialysis]
Renal recovery may best be defined as a reduction in AKI stage at 24 hours after the start of cool blood continuous dialysis treatment determined by creatinine level and urine output.
- Low blood pressure [Through study completion, an average of 60 days]
Systolic blood pressure less than 90mmHg or more than 20mmHg fall below baseline; 10% increase in vasopressor dose leading to an increase in blood pressure.
- Cumulative vasopressor dose [Through study completion, an average of 60 days]
Dose of vasopressor drugs - unit dependent on drug
- Patient's Core Body Temperature (Celsius degrees) [Through study completion, an average of 60 days]
Core body temperature as measured with SpotOn device
- Temperature of venous blood in return line (Celsius degrees) [Through study completion, an average of 60 days]
Blood temperature measured with SpotOn device
- Intensive care unit free days [After an average of 60 days in the ICU]
Number of days that a participant has been discharged from the ICU while admitted to the hospital
- ICU length of stay [Through study completion, an average of 60 days]
Number of days a participant stayed in the ICU
- Hospital length of stay [Through study completion, an average of 60 days to hospital discharge]
Number of days a participant stayed in the hospital
- ICU mortality [Through study completion, an average of 60 days]
Mortality rate during ICU admission
- In Hospital Mortality [Through study completion, an average of 60 days to hospital discharge]
Mortality rate during in hospital stay
- 60-day Mortality [From study start to up to 60 days from study start]
Mortality rate within the 60 day period
- Temperature correlation between nasopharyngeal, forehead, and oral temperature measurements [From study start to up to 60 days from study start]
To correlate invasive measurements of core body temperature (nasopharyngeal) with non-invasive oral and forehead temperature monitoring using the SpotOn system
Eligibility Criteria
Criteria
Inclusion Criteria:
-
AKI as defined by 2012 AKI KDIGO guidelines requiring CRRT.
-
Patient's core temperature between 35°C and 40°C at the time of recruitment.
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Age 18 years old and older.
Exclusion Criteria:
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Hypothermia (patient core temperature <35°C) at the time of recruitment
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Extreme hyperthermia or hyperpyrexia (patient core temperature >40°C) at the time of recruitment.
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Contraindication to cooling (e.g., hemorrhagic shock or severe coagulopathy)
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Patients undergoing targeted temperature management for cardiac arrest.
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Chronic kidney disease stage 5 as defined by CKD KDIGO guidelines [19] requiring renal replacement therapy prior to recruitment.
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Receiving palliative care or immediate plans for withdrawal of life sustaining therapy at the time of recruitment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Critical Care Trauma Centre | London | Ontario | Canada | N6A 5W9 |
Sponsors and Collaborators
- Lawson Health Research Institute
Investigators
- Principal Investigator: Marat Slessarev, MD, Lawson Health Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 113951