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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Institut Paoli Calmettes
RECRUITING
Marseille
Contact Information
Primary
Dominique GENRE, MD
drci.up@ipc.unicancer.fr
+33 4 91 22 37 78
Backup
Carine Feuillet, PhD
drci.up@ipc.unicancer.fr
+33 4 91 22 34 48
Time Frame
Start Date: 2022-02-03
Estimated Completion Date: 2026-05-15
Participants
Target number of participants: 186
Treatments
Experimental: 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.
Other: 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.
Sponsors
Leads: Institut Paoli-Calmettes

This content was sourced from clinicaltrials.gov