2023-506512-40-00招募中3 期
Effect of low-dose arginine-vasopressin supplementation on post-transplant Acute Kidney Injury after liver transplantation - AVENIR Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 304
- 试验地点
- 7
- 主要终点
- Stages of AKI according to AKI Network criteria (KDIGO score) during the first 7 postoperative days
研究概览
简要总结
To demonstrate that intraoperative low-dose supplementation of AVP induces a reduction in post-transplant AKI after liver transplantation.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Any adult patient with a scheduled liver transplantation
- •All participants will need to be given clear information about the study and give signed informed consent
- •Person affiliated to the Social Security
排除标准
- •Super-emergency for liver transplantation or fulminant hepatitis
- •Pregnancy or breastfeeding
- •Patient listed for or receiving simultaneous liver-kidney transplantation (SLKT)
- •Patients with end-stage renal disease (chronic eGFR < 15 mL/min/1.73 m2 or requiring extra-renal purification before liver transplantation
- •Patient with epilepsy
- •Hypersensitivity to arginine-vasopressin and to its excipients
- •Patient refusal
- •Patients for whom it is impossible to give informed consent (language barrier)
- •Adults under guardianship or trusteeship, persons deprived of their liberty
- •Patient enrolled in another interventional clinical study
结局指标
主要结局
Stages of AKI according to AKI Network criteria (KDIGO score) during the first 7 postoperative days
Stages of AKI according to AKI Network criteria (KDIGO score) during the first 7 postoperative days
次要结局
- Average intraoperative norepinephrine concentrations
- The number of packed red blood cells and fresh frozen plasma transfused intraoperatively and during the first 12 hours postoperatively
- The need for renal replacement for replacement therapy (RRT) in ICU
- Average intraoperative concentrations of other vasopressors and inotropes (Adrenalin, Dobutamine)
- Number of platelets transfused intraoperatively and during the first 12 hours postoperatively
- Amount of vascular filling solutions intraoperatively and during the first 12 hours postoperatively
- Sequential Organ Failure Assessment (score SOFA) on the third postoperative day
- Number of days alive outside intensive care unit during the 30 day post-operation
- Mortality at 30 days
研究者
Pr Jacques DURANTEAU
Scientific
Assistance Publique Hopitaux De Paris
研究点 (7)
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