Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery

NCT04655885 | Recruiting

• 1 other identifier: OPTILIVER TRIAL-IPC 2018-022
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of the cardiac output optimization strategy on the occurrence of postoperative complications

  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.

  From Day 1 to Day 30 post-surgery

Secondary Outcomes (5)

• Evaluation of grade III-IV postoperative complication in the Dindo-Clavien classification

  From Day 1 to Day 30 post-surgery

• Evaluation of length of stay in the hospital

  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 hemodynamic parameters

  From Day 0 to Day 1 post-surgery

Study Arms (2)

Optimization of cardiac flow by base water-electrolyte supply

EXPERIMENTAL

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: Optimization of cardiac flow by base water-electrolyte supply

Control arm

OTHER

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.

Behavioral: Control arm

Interventions

Optimization of cardiac flow by base water-electrolyte supply 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.

Optimization of cardiac flow by base water-electrolyte supply

Control arm 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.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

RECRUITING

Study Officials

• Jean-Manuel de Guibert, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique GENRE, MD

CONTACT

+33 4 91 22 37 78; drci.up@ipc.unicancer.fr

Carine Feuillet, PhD

CONTACT

+33 4 91 22 34 48; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 7, 2020
• Study Start: February 3, 2022
• Primary Completion: March 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

FR (1)