NCT04655885

Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Primary or Metastatic Hepatic Adenocarcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Optimization of cardiac flow by base water-electrolyte supply	optimization of cardiac flow by base water-electrolyte supply of 1 ml / kg / h by Ringer Lactate® and faced with any decrease of more than 10% of the VES compared to the reference VES, achievement of an optimization of the preload by administration of 250 ml of Ringer Lactate® with renewal until correction of the VES.
BEHAVIORAL	Control arm	increase basic hydro-electrolyte supply of 6 ml / kg / h by Ringer Lactate® and 1: 1 blood loss compensation by crystalloids of the same nature.

Timeline

• Start date: 2022-02-03
• Primary completion: 2026-03-15
• Completion: 2026-05-15
• First posted: 2020-12-07
• Last updated: 2024-04-09

Locations

1 site across 1 country: France