Effect of an Individualized Protocol Based on Cardiac Output Optimization Guided by Dynamic Indices of Preload Responsiveness Monitoring on Postoperative Complications in Major Hepatic Surgery for Primary or Secondary Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Evaluation of the cardiac output optimization strategy on the occurrence of postoperative complications
研究概览
简要总结
Major hepatectomies are high-risk surgeries offered more and more frequently for the curative treatment of primary or secondary liver cancer, and for complex cases, representing a real challenge for medical teams. The 1st peroperative phase of "hepatic resection" requires a minimum supply of filling fluids to limit perioperative bleeding (Low Central Venous Pressure). However this strategy exposes the risk of organ hypoperfusion due to low cardiac flow, secondary to hypovolaemia, which may lead to ischemic situations favoring the onset of postoperative complications. On the other hand, the hemodynamic management of the 2nd peroperative phase "post hepatic resection" is marked by the need to correct this hypoperfusion by optimizing cardiac output by suitable vascular filling.
The major challenge is thus to restore cardiac output by refilling without excess, by correcting the hypovolemia that arose during the "post resection of the hepatic parenchyma" phase.
Our hypothesis is that an individualized protocol for optimizing intraoperative cardiac flow by guided vascular filling during the "post hepatic resection" phase is accompanied by a reduction in postoperative complications in patients operated on for major hepatic 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
- 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
- •Age ≥ 18 years old,
- •Signature of consent,
- •Any patient scheduled for major hepatic surgery (≥ 3 segments) scheduled by laparotomy, for primary hepatic cancer or secondary metastases,
- •Affiliation to the ''National security'' regimen or beneficiary of this regimen.
排除标准
- •Emergency surgery,
- •Cirrhosis: depending on availability of CT and / or MRI imaging results, clinical examination, Biology (PT, Bilirubin) or histological results (preoperative biopsies in healthy liver)
- •Portal hypertension: depending on availability of imaging data, history of esophageal varices
- •Contraindication to fitting a tool for monitoring dynamic hemodynamic indices (case of esophageal varices for esophageal Doppler for example),
- •Benign tumors,
- •Associated procedures programmed at the same operating time (excluding hepatic surgery): programmed associated digestive resection (colorectal or pancreatic),
- •Laparoscopy,
- •Liver transplantation,
- •Woman pregnant or likely to be (without effective contraception) or breastfeeding,
- •Person in an emergency situation, adult person subject to a legal protection measure (adult under guardianship, guardianship or legal protection), or unable to express consent,
- •Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
结局指标
主要结局
Evaluation of the cardiac output optimization strategy on the occurrence of postoperative complications
时间窗: From Day 1 to Day 30 post-surgery
Assessment of the impact of an individualized protocol for optimizing perioperative cardiac flow guided by monitoring of dynamic indices of preload dependence during the post-hepatic resection phase on the occurrence of postoperative complications in major hepatic surgery, for primary hepatic cancer or metastatic origin. We retain as the primary endpoint, the percentage of patients with at least one postoperative complication regardless of the grade in the Dindo-Clavien classification.
次要结局
- Evaluation of grade III-IV postoperative complication in the Dindo-Clavien classification(From Day 1 to Day 30 post-surgery)
- Evaluation of mortality(On Day 1, Day 30 and Day 90 post-surgery)
- Evaluation occurrence of organ failures(From Day 1 to Day 7 post-surgery)
- Evaluation of length of stay in the hospital(From Day 1 to Day 30 post-surgery)
- Evaluation of hemodynamic parameters(From Day 0 to Day 1 post-surgery)