Lactate Clearance After Remote Ischaemic Preconditioning in Liver Resections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Lactate clearance
研究概览
简要总结
The primary aim of the study is the evaluation of the efficacy of remote ischemic preconditioning (RIPC) in terms of increase of the clearance of lactates 4 hours after the end of the hepatic resection. The secondary aims of the study are represented by the evaluation of the patients' postoperative recovery and the restoration of a normal lactate metabolism.
详细描述
Hepatic surgery includes clamping of the hepatic peduncle (Pringle maneuver) to control intraoperative bleeding with a consequent reduction of postoperative complications. Surgical manipulations and Pringle maneuver, especially if prolonged and/or repeated, can cause ischemia-reperfusion damage. The technique of regional ischemic preconditioning was introduced to improve tolerance to ischemia. However, the scientific evidence currently does not support the routine use of regional ischemic preconditioning in hepatic surgery. It has recently been demonstrated that ischemic preconditioning can be effective when performed in the upper limb (RIPC). The main advantages of the remote ischaemic preconditiong compared to the regional one are the ease of use, the reduction of surgical time and hepatic ischemia.
One of the most relevant epiphenomena of hepatic ischemia during hepatectomy is an increase in lactate levels in the immediate postoperative period that can be associated with an unfavorable outcome and can affect relevant clinical choices such as admission to intensive care. However, no previous studies have investigated the effectiveness of RIPC in improving lactate clearance after liver resection.
The investigators hypothesized that applying RIPC before the start of the hepatic resection and the associated Pringle maneuvers could significantly increase lactate clearance 4 hours after the end of liver resection.
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
- 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
- •Elective liver surgey (laparotomic, laparoscopic and robotic-assisted)
- •Signed informed consent
排除标准
- •Age <18 years
- •Previous liver intervention including surgical and non surgical approach such as liver radiofrequency ablation and radiation therapy
- •Severe cardiopulmunary diseases
- •Refusal to participate
结局指标
主要结局
Lactate clearance
时间窗: 4 hours after the end of liver resection
(lactate at the end of liver resection minus lactate at 4 hours after the end of liver resection)\*100 to lactate at the end of liver resection
次要结局
- Postoperative recovery(hours (RR) or days (ICU), and average of three hours for RR and one day in ICU)
- Trend of lactate clearance(1, 4 and 24 hours after the end of liver resection)
- In-hospital stay(Days until discharge, an average of 7 days)