Does Terlipressin Improve Renal Outcome After Liver Surgery - A Double-Blinded Randomized Control Trial (TIROL-Trial)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- serum creatinine peak level within 48 hours post-operative
研究概览
简要总结
The investigators aim to address whether terlipressin improves the renal outcome after liver surgery. Therefore the investigators are planning to conduct a double-blinded randomized control trial. The investigators will randomize patients undergoing any kind of liver surgery and being at increased moderate to high risk for post-operative acute renal failure into a control group receiving post- operative a placebo or into a group receiving post-operatively terlipressin in combination with human albumin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •>=12% risk for post-operative ARF on our recently developed and validated prediction score for ARF after liver surgery, patients will need five points or more in the pre-operative assessment of the predictors to be enrolled in the trial
排除标准
- •< 18 years
- •liver cirrhosis
- •coronary insufficiency with ST-elevation or ST-depression in the - - intra-operative ECG as signs of an acute coronary syndrome
- •pregnancy and breast feed
研究组 & 干预措施
Control Group
Patients receiving post-operative placebo (Ringer lactate solution) treatment to preserve the renal function
干预措施: Placebo (Drug)
Terlipressin Group
Patients receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function
干预措施: Terlipressin (Drug)
结局指标
主要结局
serum creatinine peak level within 48 hours post-operative
时间窗: within 48 hours post-operative
次要结局
- Morbidity & mortality(Post Operative Day 0 - 14)
- length of ICU stay(Post Operative Day 0 - 7)
- the urinary output/24h(Post Operative Day 0 to 3)
- Liver function(Post Operative Day 0 - 5)
- length of hospital stay(Post Operative Day 0 - 14)
- Need for hemofiltration and/or hemodialysis(Post Operative Day 0 - 14)
研究者
Ksenija Slankamenac
MD PhD
University of Zurich