Volatile Anesthetic Protection Of Renal Transplants 2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 5
- 主要终点
- Incidence of delayed graft function and/or one year acute rejection
研究概览
简要总结
To compare the effect of a sevoflurane based anesthesia versus a propofol based anesthesia on the incidence of DGF in recipients of kidneys of donation after circulatory death (DCD) and donation after brain death (DBD) donors
详细描述
Objective:
To compare the effect of a sevoflurane based anaesthesia versus a propofol based anaesthesia on the incidence of delayed graft function in recipients of DCD and DBD donor kidneys.
Study design:
Prospective randomized controlled European multicentre clinical trial with two parallel groups
Study population:
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
- Single (Participant)
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
- •Age > 18 years
- •Written informed consent
排除标准
- •high immunological risk as determined bij local practice
- •Patients of the ABO-incompatible program
研究组 & 干预措施
sevoflurane
Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based general anesthesia.
干预措施: sevoflurane (Drug)
propofol
Group 1 PROP (control): propofol: a propofol-remifentanil based general anesthesia.
干预措施: propofol (Drug)
结局指标
主要结局
Incidence of delayed graft function and/or one year acute rejection
时间窗: DGF: 7 days after transplantation Acute rejection: up to 1 year after transplantation
DGF is defined as need of dialysis first 7 days after transplantation Acute rejection up to 1 year after transplantation, defined by the modified BANFF 2013 classification and must be associated with decline in kidney function and treatment.
次要结局
- incidence of primary non function (PNF)(up to 3 months after transplantation)
- Estimated Glomerular Filtration Rate (GFR)(7 days after transplantation, 3 months after transplantation, 1 year after transplantation)
- Incidence of funactional Delayed Graft Function(7 days after transplantation)
- Length of hospital stay(From day of transplantation until the day of discharge, assessed up to 60 days)
- Postoperative complications of all kind(from the day of transplantation until the day of discharge, assessed up to 60 days)
- hospital readmissions after transplantation(3 months after transplantation and between 3 months and 1year after transplantation)
- Graft survival(up to 1 year after transplantation)
- All-cause mortality(up to 1 year after transplantation)
- measured GFR employing Iodinethalamate (Groningen), CrEDTA (Aarhus) and Iohexol (Oslo) at twelve months(1 year after transplantation)
研究者
Gertrude J. Nieuwenhuijs-Moeke, MD PhD
MD PhD
University Medical Center Groningen