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Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
Sponsor: Assistance Publique - Hôpitaux de Paris
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
Conditions
Interventions
Routine care
Fluid administration will be given per routine care MAP between 65 - 70 mmHg
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