Actively Recruiting
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-08
2000
Participants Needed
17
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Undergoing elective high-risk abdominal surgery (open or laparoscopically assisted)
- American Society of Anesthesiologists physical status greater than 2
- Exercise tolerance less than 4 metabolic equivalents
- Renal impairment (serum creatinine 1.3 mg/dL or estimated glomerular filtration rate below 90 mL/min/1.73 m2 within 6 months) or on renal replacement therapy
- Coronary artery disease at any stage
- Chronic heart failure (New York Heart Association Functional Classification II or higher)
- Moderate or severe valvular heart disease
- History of stroke
- Peripheral arterial occlusive disease at any stage
- Chronic obstructive pulmonary disease or pulmonary fibrosis at any stage
- Diabetes mellitus requiring oral medication or insulin
- Immunodeficiency due to disease or therapy
- Liver cirrhosis of any Child-Pugh class
- Body mass index 30 kg/m2 or higher
- Current smoker or 15 pack-year smoking history
- Able to give signed informed consent after receiving study information
You will not qualify if you...
- Patients with preoperative cardiac arrhythmias such as atrial fibrillation
- No affiliation with the French health care system
- Participation in another randomized controlled trial with similar endpoints or conflicting interventions
- Pregnant patients
- Patients on state medical aid (AME) unless exempted
- Patients under guardianship, legal protection, or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
University of California IRVINE
Irvine, California, United States, 92868
Actively Recruiting
2
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Actively Recruiting
3
UZ Brussels
Brussels, Brussels Capital, Belgium
Actively Recruiting
4
CHUM Montreal
Montreal, Montreal, Canada
Actively Recruiting
5
Chu Dijon
Dijon, Dijon, France
Actively Recruiting
6
ALEXANDRE JOOSTEN, MD PhD
Le Kremlin-Bicêtre, France, France, 94200
Actively Recruiting
7
Chu Grenoble Alpes
Grenoble, Grenoble, France
Actively Recruiting
8
Centre chirurgical Marie Lannelongue
Le Plessis-Robinson, Haut de Seine, France
Actively Recruiting
9
BICETRE
Le Kremlin-Bicêtre, Paris, France
Actively Recruiting
10
BEAUJON
Paris, Paris, France
Actively Recruiting
11
HEGP
Paris, PARIS, France
Actively Recruiting
12
Insititut Mutualiste Montsouris
Paris, Paris, France
Actively Recruiting
13
La Pitie Salpetriere
Paris, PARIS, France
Actively Recruiting
14
Chu Toulouse
Toulouse, Toulouse, France
Actively Recruiting
15
Chu Lille
Lille, France
Actively Recruiting
16
Centre hospitalier universitaire de NANCY
Nancy, France
Actively Recruiting
17
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany
Not Yet Recruiting
Research Team
A
ALEXANDRE JOOSTEN, MD PhD
CONTACT
J
Jacques DURANTEAU, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here