Improving Outcomes in Patients Receiving Continuous Renal Replacement Therapy for Acute Kidney Injury by Cooling Blood in the Dialysis Circuit (CRRiTiCool): a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Regional Wall Motion Abnormalities
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Age 18 years old and older.
排除标准
- •Hypothermia (patient core temperature <35°C) at the time of recruitment
- •Extreme hyperthermia or hyperpyrexia (patient core temperature >40°C) at the time of recruitment.
- •Contraindication to cooling (e.g., hemorrhagic shock or severe coagulopathy)
- •Patients undergoing targeted temperature management for cardiac arrest.
- •Chronic kidney disease stage 5 as defined by CKD KDIGO guidelines [19] requiring renal replacement therapy prior to recruitment.
- •Receiving palliative care or immediate plans for withdrawal of life sustaining therapy at the time of recruitment.
研究组 & 干预措施
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.
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.
干预措施: Dialysis cooling (Procedure)
结局指标
主要结局
Regional Wall Motion Abnormalities
时间窗: 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
次要结局
- Regional Wall Motion Abnormalities at 7 days(Seven days after the start of cool blood delivery 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)
- 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)
- Temperature of venous blood in return line (Celsius degrees)(Through study completion, an average of 60 days)
- Duration of Continuous Renal Replacement Therapy (CRRT)(Through study completion, an average of 60 days)
- Hospital length of stay(Through study completion, an average of 60 days to hospital discharge)
- Low blood pressure(Through study completion, an average of 60 days)
- ICU length of stay(Through study completion, an average of 60 days)
- 60-day Mortality(From study start to up to 60 days from study start)
- 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)
- Cumulative vasopressor dose(Through study completion, an average of 60 days)
- Patient's Core Body Temperature (Celsius degrees)(Through study completion, an average of 60 days)
- In Hospital Mortality(Through study completion, an average of 60 days to hospital discharge)
- Intensive care unit free days(After an average of 60 days in the ICU)
- ICU mortality(Through study completion, an average of 60 days)
- Temperature correlation between nasopharyngeal, forehead, and oral temperature measurements(From study start to up to 60 days from study start)
研究者
Marat Slessarev
Assistant Professor of Medicine
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's