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Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery (OPTILIVER)

Primary Purpose

Primary or Metastatic Hepatic Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Optimization of cardiac flow by base water-electrolyte supply
Control arm
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Primary or Metastatic Hepatic Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Paoli CalmettesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Optimization of cardiac flow by base water-electrolyte supply

Control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluation of grade III-IV postoperative complication in the Dindo-Clavien classification
To determine whether the strategy for optimizing cardiac output guided by dynamic dependence preload indices is associated with a difference in the incidence of occurrence of at least one grade III-IV postoperative complication in the Dindo-Clavien classification
Evaluation of length of stay in the hospital
To determine whether the cardiac output optimization strategy guided by the dynamic dependence preload indices is associated with a difference in the length of stay in the Continuing Care Unit, intensive care unit or length of hospital stay or on re-hospitalization rates
Evaluation of mortality
To determine whether the cardiac output optimization strategy guided by the dynamic dependence preload indices is associated with a difference in mortality at D30 and D90
Evaluation occurrence of organ failures
To determine whether the cardiac output optimization strategy guided by dynamic dependence preload indices has an impact on the occurrence of organ failures, which will be evaluated by the SOFA score per device from Day 1 to Day 7 postoperatively
Evaluation of hemodynamic parameters
To determine whether the cardiac output optimization strategy guided by dynamic dependence preload indices is associated with a difference on hemodynamic parameters

Full Information

First Posted
November 27, 2020
Last Updated
March 8, 2022
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT04655885
Brief Title
Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery
Acronym
OPTILIVER
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
March 3, 2024 (Anticipated)
Study Completion Date
May 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary or Metastatic Hepatic Adenocarcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Optimization of cardiac flow by base water-electrolyte supply
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Other
Arm Description
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
Intervention Name(s)
Optimization of cardiac flow by base water-electrolyte supply
Intervention Description
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
Intervention Name(s)
Control arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the cardiac output optimization strategy on the occurrence of postoperative complications
Description
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.
Time Frame
From Day 1 to Day 30 post-surgery
Secondary Outcome Measure Information:
Title
Evaluation of grade III-IV postoperative complication in the Dindo-Clavien classification
Description
To determine whether the strategy for optimizing cardiac output guided by dynamic dependence preload indices is associated with a difference in the incidence of occurrence of at least one grade III-IV postoperative complication in the Dindo-Clavien classification
Time Frame
From Day 1 to Day 30 post-surgery
Title
Evaluation of length of stay in the hospital
Description
To determine whether the cardiac output optimization strategy guided by the dynamic dependence preload indices is associated with a difference in the length of stay in the Continuing Care Unit, intensive care unit or length of hospital stay or on re-hospitalization rates
Time Frame
From Day 1 to Day 30 post-surgery
Title
Evaluation of mortality
Description
To determine whether the cardiac output optimization strategy guided by the dynamic dependence preload indices is associated with a difference in mortality at D30 and D90
Time Frame
On Day 1, Day 30 and Day 90 post-surgery
Title
Evaluation occurrence of organ failures
Description
To determine whether the cardiac output optimization strategy guided by dynamic dependence preload indices has an impact on the occurrence of organ failures, which will be evaluated by the SOFA score per device from Day 1 to Day 7 postoperatively
Time Frame
From Day 1 to Day 7 post-surgery
Title
Evaluation of hemodynamic parameters
Description
To determine whether the cardiac output optimization strategy guided by dynamic dependence preload indices is associated with a difference on hemodynamic parameters
Time Frame
From Day 0 to Day 1 post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
+33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Carine Feuillet, PhD
Phone
+33 4 91 22 34 48
Email
drci.up@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Manuel de Guibert, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GENRE Dominique, MD
Phone
+ 33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
GOUARNE Caroline, PhD
Phone
+ 33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr

12. IPD Sharing Statement

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Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery

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