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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Cooling the blood in the CRRT circuit during delivery
Critical Care Trauma Centre
London, Ontario, Canada
Regional Wall Motion Abnormalities
Number of segments undergoing a 20% reduction in longitudinal systolic strain
Time frame: At the end of delivery of cool blood during continuous dialysis; 12 to 24 hours
Regional Wall Motion Abnormalities at 7 days
Number of segments undergoing a 20% reduction in longitudinal systolic strain after delivery of cool blood during continuous dialysis
Time frame: Seven days after the start of cool blood delivery during continuous dialysis
Regional Wall Motion Abnormalities at ICU discharge
Number of segments undergoing a 20% reduction in longitudinal systolic strain at ICU discharge
Time frame: At ICU discharge, an average of 60 days after the start of cool blood delivery during continuous dialysis
Duration of Continuous Renal Replacement Therapy (CRRT)
Number of hours of CRRT therapy during ICU admission
Time frame: Through study completion, an average of 60 days
Renal Recovery at 7 days after cool blood continuous dialysis requiring acute kidney injury
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.
Time frame: Seven days after the start of cool blood delivery during continuous dialysis
Renal Recovery at 24 hours after cool blood continuous dialysis requiring acute kidney injury
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.
Time frame: 24 hours after the start of cool blood delivery during continuous dialysis
Low blood pressure
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.
Time frame: Through study completion, an average of 60 days
Cumulative vasopressor dose
Dose of vasopressor drugs - unit dependent on drug
Time frame: Through study completion, an average of 60 days
Patient's Core Body Temperature (Celsius degrees)
Core body temperature as measured with SpotOn device
Time frame: Through study completion, an average of 60 days
Temperature of venous blood in return line (Celsius degrees)
Blood temperature measured with SpotOn device
Time frame: Through study completion, an average of 60 days
Intensive care unit free days
Number of days that a participant has been discharged from the ICU while admitted to the hospital
Time frame: After an average of 60 days in the ICU
ICU length of stay
Number of days a participant stayed in the ICU
Time frame: Through study completion, an average of 60 days
Hospital length of stay
Number of days a participant stayed in the hospital
Time frame: Through study completion, an average of 60 days to hospital discharge
ICU mortality
Mortality rate during ICU admission
Time frame: Through study completion, an average of 60 days
In Hospital Mortality
Mortality rate during in hospital stay
Time frame: Through study completion, an average of 60 days to hospital discharge
60-day Mortality
Mortality rate within the 60 day period
Time frame: From study start to up to 60 days from study start
Temperature correlation between nasopharyngeal, forehead, and oral temperature measurements
To correlate invasive measurements of core body temperature (nasopharyngeal) with non-invasive oral and forehead temperature monitoring using the SpotOn system
Time frame: From study start to up to 60 days from study start
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