Restrictive- vs Individualized Goal Directed Fluid Therapy in Liver Surgery (REVOLUTION)

December 11, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Restrictive- vs. Individualized Assisted Fluid Management in Patients Undergoing Major Liver Resection Surgery: A Randomized Controlled Trial

"Low central venous pressure (low-CVP) or a restrictive fluid administration strategy is usually used worldwide during major liver resection surgery. Although individualized goal directed fluid therapy (GDFT) has been associated with reduced morbidity and mortality in major abdominal surgery, concerns remain on blood loss when applying GDFT in liver surgery. Indeed, GDFT could lead to a higher CVP with the risk of increased blood loss and reduced quality of the surgical field especially during liver dissection.

Since evidence is scarce, this randomized controlled trial investigates the impact of a restrictive vs an individualized GDFT strategy assisted by an assisted fluid management (AFM) system on lactate level, blood loss, and postoperative morbidity including acute kidney injury (AKI) in major liver resections."

Study Overview

Detailed Description

Major liver resection surgery is a frequent but complex surgery with high morbidity, even in high activity centers. The morbidity is mainly related to the size of the liver resection and to bleeding, responsible for postoperative hepatocellular failure.

Intraoperative fluid administration is a major component of the anesthetic strategy to optimize the hemodynamic status and peripheral tissue perfusion of the patient. However, high-level evidence recommendations are still lacking regarding the optimal fluid strategy in patients undergoing major liver resection.

On the one hand, it has been accepted for decades that anesthetic management should focus on minimizing intraoperative bleeding by limiting fluid administration. The objective of a ""restrictive"" fluid strategy has often been to maintain a low central venous pressure (CVP), allowing to decrease the venous pressure at the level of the suprahepatic veins and the hepatic section. The lower this pressure, the more limited the bleeding by ""backflow"". This strategy is supported by surgeons because it allows them to maintain a relatively bloodless operating field (by reducing bleeding) and thus facilitates their dissection/surgical work. Under these conditions, however, an infusion of vasopressors is often necessary to maintain adequate perfusion pressure to all organs. In addition, a ""liberal"" fluid administration is often required after liver transection to compensate for blood loss and delayed vascular filling accumulated during most of the surgical procedure. This strategy therefore potentially exposes the patient to the deleterious effects of hypovolemia as reflected by an increase in blood lactate levels. Lactate is considered an indirect marker of the degree of tissue hypoperfusion.

On the other hand, in high-risk abdominal surgery, the anesthesia community recommends a more ""individualized"" fluid strategy, based on the optimization of stroke volume also called ""goal directed fluid therapy"" (GDFT) with the aim of decreasing postoperative complications. It is now even possible to apply this strategy using a real time clinical decision support system (""assisted fluid management"" or AFM). However, the concept of GDFT assisted by AFM (GDFT-AFM) could possibly be accompanied by an increase in CVP and therefore intraoperative bleeding. However, to date, no randomized study has compared these 2 fluid therapy strategies (restrictive vs GDFT-AFM) on lactate level as the primary outcome "

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • VAL DE Marne
      • Villejuif, VAL DE Marne, France, 94800
        • PAUL BROUSSE, centre hepato -biliaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient
  • Major liver surgery

Exclusion Criteria:

-arrythmia -Linguistic barrier -Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: restrictive fluid therapy group
Patients in this group will have a restrictive fluid therapy (1 ml/kh/h) from anesthesia induction until end of liver resection.
from anesthesia induction until end of the liver resection, patient will have a restrictive fluid therapy strategy
Experimental: individualized GDFT group
In this group, from anesthesia induction until skin closure, fluid will be given to the patients based on the recommendation of the AFM software in order to optimize patient's stroke volume (SV)
In this group, from anesthesia induction until skin closure, fluid will be given to the patients based on the recommandation of the AFM software in order to optimize patient's SV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lactate level at the end of the surgery
Time Frame: Up to the end of surgenry (intraoperatively)
lactate level measured at the end of the surgery (skin closure)
Up to the end of surgenry (intraoperatively)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total intraoperative blood loss
Time Frame: Up to the end of surgenry (intraoperatively)
We will measure blood loss at the end of the surgery
Up to the end of surgenry (intraoperatively)
Total amount of vasopressors used during surgery
Time Frame: Up to the end of surgenry (intraoperatively)
We will report the total amount of vasopressor used during surgery
Up to the end of surgenry (intraoperatively)
Total amount of fluid used during surgery
Time Frame: end of the surgery
We will report the total amount of fluid used during surgery
end of the surgery
Incidence of acute kidney injury (AKI)
Time Frame: postoperative day 7
We will report the incidence of AKI at postoperative day 7 using the KDIGO classification
postoperative day 7
Incidence of postoperative complications
Time Frame: postoperative day 30
We will report the incidence of postoperative complications using the clavien dindo classification
postoperative day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: ALEXANDRE JOOSTEN, MD PhD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2022

Primary Completion (Actual)

August 14, 2023

Study Completion (Actual)

August 14, 2023

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • APHP 220682

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery-Complications

Clinical Trials on Restrictive fluid therapy strategy

3
Subscribe