Intra-Operative Continuous Renal Replacement Therapy in Liver Transplantation: A Phase II Randomized Controlled Trial (INCEPTION)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of patients adhering to the prescribed protocol
研究概览
简要总结
Patient with liver failure waiting for liver transplantation are often hospitalized and commonly supported in an intensive care unit prior to surgery. These patients are sick, and in addition to the complications of a failing liver, other organs such as the kidneys often fail as well. As a consequence, these patients are at an increased risk for complications related to their kidney failure during their liver transplantation procedure. One potential method to diminish the risk of these complications is to provide dialysis support to these patients during their liver transplantation in the operating theater in the form of continuous renal replacement therapy (CRRT). While this is increasingly being performed and is theoretically appealing, there is very little information to support this practice. In addition, the use of CRRT during surgery is not entirely without risk. The investigators have performed two preliminary studies on the use of CRRT during liver transplantation and our data would strongly support the need to conduct further higher-quality studies to better evaluate its feasibility, safety and usefulness. Our proposed study is for a randomized trial comparing the use of CRRT during surgery with standard supportive care in sick patients with liver failure scheduled to receive a liver transplantation.
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
- •Adult (age > 18 years on the day of assessment of eligibility)
- •Planned cadaveric orthotopic liver transplantation
- •Pre-operative unadjusted (natural) Modification of End-Stage Liver Disease (MELD) score >
- •Pre-operative AKI, defined by a minimum RIFLE-RISK, AND/OR pre-operative estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, calculated by the Modification of Diet in Renal Disease (MDRD) equation.
排除标准
- •Planned living-related donor liver transplantation
- •Pre-operative potassium [K] > 4.5 mmol/L AND urine output < 100 mL in the 6 hrs preceding assessment of eligibility
- •Pre-operative pH < 7.3
研究组 & 干预措施
Standard intraoperative support (no CRRT)
干预措施: Standard intraoperative support (Procedure)
Intraoperative renal support (CRRT)
干预措施: Continuous renal replacement therapy (CRRT) (Device)
结局指标
主要结局
Number of patients adhering to the prescribed protocol
时间窗: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)
Will be defined as the proportion of patients adhering to the prescribed protocol.
Number of patients with adverse events
时间窗: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)
This will be defined by the proportion of patients experiencing intra-operative adverse events, serious adverse events and complications related to the study intervention.
次要结局
- Fluid balance(In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively))
- Number of patients with post-operative graft dysfunction(In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively))
- Number of patients with post-operative kidney dysfunction(From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days)
- Length of stay(From the date of liver transplant until the date of discharge from ICU/hospital)
- Mortality(From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days)
- Number of patients readmitted to hospital within 90-days(From the date of liver transplant after hospital discharge, until the date of first documented re-admission to hospital, assessed until 90-days)
研究者
Sean M Bagshaw
Assistant Professor
University of Alberta