Restrictive- vs Individualized Goal Directed Fluid Therapy in Liver Surgery

NCT05704387 | Completed

• 1 other identifier: APHP220682
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

"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."

Conditions

Surgery-Complications

Keywords

liver; hemodynamic optimization

Outcome Measures

Primary Outcomes (1)

• Lactate level at the end of the surgery

  lactate level measured at the end of the surgery (skin closure)

  Up to the end of surgenry (intraoperatively)

Secondary Outcomes (5)

• Total intraoperative blood loss

  Up to the end of surgenry (intraoperatively)

• Total amount of vasopressors used during surgery

  Up to the end of surgenry (intraoperatively)

• Total amount of fluid used during surgery

  end of the surgery

• Incidence of acute kidney injury (AKI)

  postoperative day 7

• Incidence of postoperative complications

  postoperative day 30

Study Arms (2)

restrictive fluid therapy group

ACTIVE COMPARATOR

Patients in this group will have a restrictive fluid therapy (1 ml/kh/h) from anesthesia induction until end of liver resection.

Procedure: Restrictive fluid therapy strategy

individualized GDFT group

EXPERIMENTAL

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)

Procedure: individualized GDFT

Interventions

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

individualized GDFT group

Restrictive fluid therapy strategy PROCEDURE

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

restrictive fluid therapy group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient
• Major liver surgery

You may not qualify if:

• arrythmia -Linguistic barrier -Pregnant women

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

PAUL BROUSSE, centre hepato -biliaire

Villejuif, VAL DE MARNE, 94800, France

Location

Study Officials

• ALEXANDRE JOOSTEN, MD PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Principal investigator, the patient, the surgeon and the outcome assessor will not know the study group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized controlled parallel superiority trial

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: January 30, 2023
• Study Start: December 27, 2022
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: September 12, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)