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RECRUITING
NCT06011187
NA

Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

Goal directed fluid therapy (GDFT) or "Personalized fluid therapy" may benefit high-risk surgical patients but these strategies are infrequently implemented. It has also been shown that without any goal or protocol for fluid resuscitation, large inter- and intra-provider variability exist that have been correlated with poor patient outcomes. Recently, an "Assisted Fluid Management" (AFM) system has been developed to help ease some of the work associated with GDFT protocol implementation. The AFM system may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This artificial intelligence-based system can suggest administration of fluid boluses, analyse the hemodynamic effects of the bolus, and continually re-assess the patient for further fluid requirements. To date, there are no large outcome study using this AFM system. The primary objective of this trial is thus to evaluate the impact of this AFM system to guide fluid bolus administration on a composite of major postoperative complications in high-risk patients undergoing high-risk abdominal surgery.

Official title: "Personalized Fluid Administration Using an AFM System for Goal Directed Fluid Therapy on Postoperative Outcome in High-risk Patients Undergoing High-risk Abdominal Surgery: A Multicenter Stepped-wedge, Cluster-randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2024-02-01

Completion Date

2026-12-30

Last Updated

2025-09-08

Healthy Volunteers

No

Interventions

PROCEDURE

Routine care

Fluid administration will be given per routine care MAP between 65 - 70 mmHg

DEVICE

AFM

AFM will recommand fluid bolus administration and MAP will be maintained between 65 and 70 mmHg

Locations (17)

University of California IRVINE

Irvine, California, United States

University of California Los Angeles (UCLA)

Los Angeles, California, United States

UZ Brussels

Brussels, Brussels Capital, Belgium

CHUM Montreal

Montreal, Montreal, Canada

Chu Dijon

Dijon, Dijon, France

ALEXANDRE JOOSTEN, MD PhD

Le Kremlin-Bicêtre, France, France

Chu Grenoble Alpes

Grenoble, Grenoble, France

Centre chirurgical Marie Lannelongue

Le Plessis-Robinson, Haut de Seine, France

BICETRE

Le Kremlin-Bicêtre, Paris, France

BEAUJON

Paris, Paris, France

HEGP

Paris, PARIS, France

Insititut Mutualiste Montsouris

Paris, Paris, France

La Pitie Salpetriere

Paris, PARIS, France

Chu Toulouse

Toulouse, Toulouse, France

Chu Lille

Lille, France

Centre hospitalier universitaire de NANCY

Nancy, France

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, Germany