Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 16
- 主要终点
- Acute Kindey Injury at Day 7
研究概览
简要总结
To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (above 30 g/L) for five days diminishes rate of AKI at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).
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
- •Male and female subjects equal or above 18 yrs old.
- •Recipients of primary liver allografts from a deceased donor (including after cardiac death) and as a single organ (liver only).
- •Capability of understanding the purpose and risks of the study.
- •Written informed consent
排除标准
- •Fulminant hepatitis
- •Kidney injury at baseline (Estimated Glomerular Filtration Rate < 50 ml/min in Modification of diet in renal disease-6) including hepatorenal syndrome
- •Use of an induction agent Basiliximab at liver transplantation
- •Protected person (adults legally protected, under judicial protection, guardianship, or supervision), person deprived of their liberty
研究组 & 干预措施
30 g/L or below
Receive Human Albumin 20% Solution when albumin serum concentration is at 30 g/L or below
干预措施: Albumin administration (Drug)
20 g/L or below
receive Human Albumin 20% Solution when albumin serum concentration is at 20 g/L or below
干预措施: Albumin administration (Drug)
结局指标
主要结局
Acute Kindey Injury at Day 7
时间窗: 7 days after liver transplantation
To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (=30 g/L) for five days diminishes rate of Acute Kindey Injury at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).
次要结局
- Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation(7 days after liver transplantation)
- occurrence of acute graft rejection(28 days)
- hospital length of stay(28 days)
- occurence of calcineurin inhibitor withdraw(28 days)
- occurrence of postoperative infections(28 days)
- occurrence of calcineurin inhibitor induced neurotoxicity(28 days)
- occurrence of early graft dysfunction(28 days)
- duration of mechanical ventilation(28 days)
- reintubation rate(28 days)
- All cause mortality(28 days)
- Intensive Care Unit length of stay(28 days)
- Intensive Care Unit readmission rate(28 days)