Phase I Clinical Trial Utilizing Direct Peritoneal Resuscitation in Liver Transplant Recipient Population at Increased Risk of Return to the Operating Room and Early Allograft Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percent of patients that complete DPR infusion without reaching stopping criteria
研究概览
简要总结
This study is being conducted to assess the safety of Direct Peritoneal Resuscitation (DPR) in high-risk liver transplant patients. The investigators want to also identify if this method of recovery after large surgery has the same benefits in liver transplant patients as have been appreciated in other surgical patients. The combination of elevated BMI and impaired kidney function increases the risk of 1) needing intensive care unit (ICU) admission after surgery, 2) slow function of the new liver [technically termed Early Allograft Dysfunction (EAD)] and 3) need for more than one operation. The study team also aims to identify if DPR can reduce these risks and not cause other unexpected complications following surgery. DPR involves the infusion of a solution into the abdomen and has been shown to reduce edema and improve blood flow in organs. The solution used in this study is a commercially available peritoneal dialysate, a dextrose containing solution that is infused into the abdominal cavity and is routinely used in patients with end-stage renal disease requiring dialysis.
详细描述
The central hypothesis of this study is that direct peritoneal resuscitation is a safe therapy following liver transplantation and is associated with a reduced rate of return to the operating room.
AIM 1: Determine the safety profile of direct peritoneal resuscitation on liver transplant recipients at risk of return to the operating room and ICU admission. Hypothesis: Liver transplant recipients that receive DPR will have comparable complication rates to historic controls of liver transplant recipients with similar demographics.
AIM 2: Identify if direct peritoneal resuscitation demonstrates a trend towards a reduced rate of return to the operating room compared to historic controls. Hypothesis: DPR will demonstrate a trend of a reduce rate of return to the operating room of liver transplant patients after index operation compared to historic controls.
AIM 3: Identify if direct peritoneal resuscitation reduces the rate of early allograft dysfunction and other organ failure following liver transplantation with interval improvement in post-operative fibrinolysis activity. Hypothesis: DPR will reduce the rate of EAD of liver transplant patients compared to historic controls and is associated with increased fibrinolysis in the post-operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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 liver transplant recipients ≥18 y/o
- •Ability to consent
- •Pre-operative Creatinine ≥1.1 (or on dialysis) and BMI ≥30
排除标准
- •Diaphragmatic injury
- •Active spontaneous bacterial peritonitis (SBP) with initiation of antibiotic treatment within 72 hours of surgery
结局指标
主要结局
Percent of patients that complete DPR infusion without reaching stopping criteria
时间窗: Up to 24 hours after initiation of direct peritoneal resuscitation
次要结局
- Abdominal compartment syndrome requiring reoperation(Events that occur during the duration of the DPR infusion, which will last no more than 24 hours after the participant's transplant surgery.)
- Rate of return to the operating room after index operation(Up to 7 days after transplant)
- Hourly urine output for first 24 hours(Up to 24 hours after transplant)
- Percent of patients that complete DPR infusion(Up to 24 hours after initiation of DPR)
- Percent of patients that are transferred to hospital ward(Up to 24 hours after surgery)
- Rate of early allograft dysfunction(Up to 7 days after transplant)
- Number of blood product units required during first 24 hours postoperatively(Up to 24 hours after transplant)
- Number of participants that require renal replacement therapy (i.e. hemodialysis) during the first 7 days after liver transplant.(Up to 7 days after transplant)
- Rate of late infection after transplant(7-30 days postoperatively)
- Rate of early infection after transplant(<7 days postoperatively)
- Duration of insulin infusion post-operatively(Up to 7 days after transplant)
- Ventilator free days(Up to 28 days post-op)
- Rate of mechanical bowel obstruction(Up to 30 days after transplant)
- Ileus/time to oral intake(Up to 30 days after transplant)