Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery

NCT ID: NCT04655885

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-03
• Study Completion Date: 2026-05-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Optimization of cardiac flow by base water-electrolyte supply

Intervention Type: BEHAVIORAL

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.

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.

Group Type: OTHER

Control arm

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old,

2. Signature of consent,

3. Any patient scheduled for major hepatic surgery (≥ 3 segments) scheduled by laparotomy, for primary hepatic cancer or secondary metastases,

4. Affiliation to the ''National security'' regimen or beneficiary of this regimen.

Exclusion Criteria

1. Emergency surgery,

2. Cirrhosis: depending on availability of CT and / or MRI imaging results, clinical examination, Biology (PT, Bilirubin) or histological results (preoperative biopsies in healthy liver)

3. Portal hypertension: depending on availability of imaging data, history of esophageal varices

4. Contraindication to fitting a tool for monitoring dynamic hemodynamic indices (case of esophageal varices for esophageal Doppler for example),

5. Benign tumors,

6. Associated procedures programmed at the same operating time (excluding hepatic surgery): programmed associated digestive resection (colorectal or pancreatic),

7. Laparoscopy,

8. Liver transplantation,

9. Woman pregnant or likely to be (without effective contraception) or breastfeeding,

10. 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,

11. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Manuel de Guibert, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Institut Paoli Calmettes

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Dominique GENRE, MD

Role: CONTACT

drci.up@ipc.unicancer.fr

+33 4 91 22 37 78

Carine Feuillet, PhD

Role: CONTACT

drci.up@ipc.unicancer.fr

+33 4 91 22 34 48

Facility Contacts

GENRE Dominique, MD

Role: primary

drci.up@ipc.unicancer.fr

+ 33 4 91 22 37 78

GOUARNE Caroline, PhD

Role: backup

drci.up@ipc.unicancer.fr

+ 33 4 91 22 37 78

Other Identifiers

OPTILIVER TRIAL-IPC 2018-022

Identifier Type: -

Identifier Source: org_study_id