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Completed

NCT Number: NCT05704387

Restrictive- vs Individualized Goal Directed Fluid Therapy in Liver Surgery

"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."

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PAUL BROUSSE, centre hepato -biliaire

Villejuif, VAL DE MARNE, 94800, France

About this study

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 "

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient
  • Major liver surgery

Exclusion criteria

-arrythmia -Linguistic barrier -Pregnant women

Treatment and study plan

individualized GDFT

Procedure

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

Restrictive fluid therapy strategy

Procedure

from anesthesia induction until end of the liver resection, patient will have a restrictive fluid therapy strategy

Primary outcomes

  1. 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)

Secondary outcomes

  1. Total intraoperative blood loss

    Time frame: Up to the end of surgenry (intraoperatively)

    We will measure blood loss at the end of the surgery

  2. 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

  3. Total amount of fluid used during surgery

    Time frame: end of the surgery

    We will report the total amount of fluid used during surgery

  4. 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

  5. Incidence of postoperative complications

    Time frame: postoperative day 30

    We will report the incidence of postoperative complications using the clavien dindo classification

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: REVOLUTION

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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