Restrictive- vs Individualized Goal Directed Fluid Therapy in Liver Surgery

Not Applicable

Completed

• Conditions: Surgery-Complications
• Interventions: Procedure: Restrictive fluid therapy strategy; Procedure: individualized GDFT

• Registration Number: NCT05704387
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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."

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 Timeline

• Study First Submitted: 2022-07-28
• Study Start: 2022-12-27
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Primary Completion: 2023-08-14
• Study Completion: 2023-08-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Adult patient
• Major liver surgery

Read More

Exclusion Criteria

-arrythmia -Linguistic barrier -Pregnant women

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
restrictive fluid therapy group	Restrictive fluid therapy strategy	Patients in this group will have a restrictive fluid therapy (1 ml/kh/h) from anesthesia induction until end of liver resection.
individualized GDFT group	individualized GDFT	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)

Primary Outcome Measures

Name	Time	Method
Lactate level at the end of the surgery	Up to the end of surgenry (intraoperatively)	lactate level measured at the end of the surgery (skin closure)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PAUL BROUSSE, centre hepato -biliaire; 🇫🇷 Villejuif, VAL DE Marne, France