Sevoflurane-induced Prevention of Ischemia-reperfusion Lesions in Renal Allograft Transplants Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- time to obtain serum creatinine levels inferior to 200µmol/l in the transplant recipient
研究概览
简要总结
Renal transplantation is characterized by ischemia-reperfusion lesions in allograft. In a previous study, Julier and al. (Anesthesiology 2003) have demonstrated that sevoflurane reduces glomerular lesions in kidney of patients undergoing a cardiovascular surgery and présenting with ischemia-reperfusion phenomena.
The purpose of the study is to evaluate the effects of sevoflurane on the recovery of renal graft function in patients after kidney transplantation.
This study will be a randomized, double blinded, controlled clinical trial and 120 patients undergoing renal allograft transplantation will be included.
Patients will be divided into 2 groups: one group of patients who will receive sevoflurane (evaluated treatment) for anaesthesia and the other one who will receive propofol (reference treatment).
We will evaluate renal function for one year after transplantation. Ours results will confirm or not that sevoflurane protects kidney function from ischemia-reperfusion lesions.
详细描述
Introduction :
Renal transplantation is characterized by ischemia-reperfusion lesions in allografts. Prolonged cold ischemia duration, age of donor (older than 50) or donor cardiac arrest are common factors associated with delayed graft function. In cardiac surgery, Sevoflurane (a volatile-inhaled anesthetic) protects the heart from ischemia-reperfusion lesions and preserves glomerular filtration function in patients. This cardioprotective effect involves K+-ATP mitochondrial channels which are also known to be expressed in renal cells.
Therefore, it is interesting to evaluate Sevoflurane effects in the context of renal allograft transplantation in order to shorten the delayed graft function and enhance post-operative renal function
Objectives:
Main goal:
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
- Double (Participant, Outcomes Assessor)
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
- •scheduled to undergo renal allograft transplantation
- •transplant : cold ischemia duration > 20 hours or donor age > 50 years or donor cardiac arrest
- •social security affiliation
- •informed consent signed
排除标准
- •halogenated anesthetic agent hypersensibility
- •medical history or familial history of malignant hyperthermia
- •porphyria
- •pregnancy or breast feeding
- •hyperimmunized patient
- •participation in an immunosuppressive drug trial
研究组 & 干预措施
P
General Anesthesia With Propofol TCI
干预措施: Propofol (Drug)
S
General Anesthesia with sevoflurane (inhalation) as hypnotic
干预措施: Sevoflurane (Drug)
结局指标
主要结局
time to obtain serum creatinine levels inferior to 200µmol/l in the transplant recipient
时间窗: evalued at 14 days
次要结局
- creatinemia levels at day 14(evalued at 14 days)
- patient survival(during 1 year follow-up)
- acute rejection occurrence(during 1 year follow-up)
- safety : renal tubular injury toxicity (serum cystatinC and NAG), serum inorganic fluor products(1, 2 and 3 days after kidney transplantation)
- other clinical end-points: daily diuresis, number of haemodialysis sessions(during the two weeks following transplantation)
- other biological end-points: serum creatinin and cystatinC levels(during the two weeks following transplantation)
- Other adverse events(during one year folow-up)