A Randomized, Double- Blind Multicentric Study of the Effect of Remote Ischemic Preconditioning on Postoperative Complications in Patients Undergoing Major Minimal and Open Visceral Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 526
- 试验地点
- 1
- 主要终点
- Postoperative Complications
研究概览
简要总结
Remote Ischemic Preconditioning (RIPC) is mediated by intermittent brief episodes (5-10 minutes) of short ischemia in a limb (i.e. arm), followed by reperfusion. For this purpose in 3-4 cycles, a tourniquet is insufflated to suprasystolic pressure levels for 5 minutes and deflated for 5 minutes afterwards. The ischemic episodes are known to stimulate platelets and factors platelet dependent factors such as Serotonin and VEGF. These humoral factors have a systemic effect and have the potential to protect target organs (i.e. heart, kidney, liver) remote to the ischemic limb.
The purpose of this randomized controlled study is to investigate the influence and impact of RIPC on postoperative complications in patients undergoing visceral surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, 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
- •> 18 years
- •Undergoing major visceral surgery
排除标准
- •< 18 years
- •Pregnancy
- •Signs of Infection/Inflammation on upper limb
- •Medical history of axillary lymph node dissection
- •Signs of malperfusion of upper limb (i.e. Allen Test)
- •Missing informed consent
研究组 & 干预措施
RIPC (Remote Ischemic Preconditioning)
Preoperatively in the operation theater a tourniquet will be applied to the left arm and RIPC will performed. Therefore the tourniquet will be insufflated to suprasystolic pressure levels for 5 minutes, followed by 5 minutes reperfusion (deflated). Three cycles are planned. Duration of the procedure is 30 minutes.
干预措施: RIPC with a tourniquet (Device)
Control
Preoperatively in the operation theater a tourniquet will be applied to the left arm. The tourniquet will not be insufflated. The tourniquet will be removed after 30 minutes.
结局指标
主要结局
Postoperative Complications
时间窗: 30 days
Complications will be assessed by Comprehensive Complication Index and Dindo Clavien Score
次要结局
- Hospital stay(30 days)
- ICU stay(30 days)
- Infection composite parameters(30 days)