Using an AI system to manage fluid therapy after high-risk abdominal surgery
"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
This study is testing whether an AI system can help doctors give the right amount of fluids to patients after high-risk abdominal surgery to see if it improves recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 17 sites (Irvine, California and 16 other locations) |
| Trial ID | NCT06011187 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of an Assisted Fluid Management (AFM) system designed to enhance goal-directed fluid therapy (GDFT) in high-risk surgical patients. The AFM system utilizes artificial intelligence to suggest fluid bolus administration, analyze hemodynamic responses, and continuously reassess patient needs, aiming to improve adherence to fluid management protocols. By addressing the variability in fluid resuscitation practices, the study seeks to determine if the AFM system can lead to better postoperative outcomes compared to routine care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older undergoing elective high-risk abdominal surgery with specific medical conditions that increase surgical risk.
Not a fit: Patients who are not undergoing high-risk abdominal surgery or do not meet the specified high-risk criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications in high-risk surgical patients.
How similar studies have performed: While there have been studies on goal-directed fluid therapy, the use of the AFM system in a large outcome study is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any adult patient (aged 18 years or older) admitted to the operating room for an elective high-risk abdominal surgery (both open and laparoscopically assisted). * Patients must fulfill at least one of the following high-risk criteria: * American Society of Anesthesiologists physical status \> 2 * classification exercise tolerance \< 4 metabolic equivalents as defined by the guidelines of the American College of Cardiology/ American Heart Association * renal impairment (serum creatinine ≥1.3mg/dL or \>115 mmol/l or estimated glomerular filtration rate \< 90 mL/min/1.73 m2 within the last 6 months) or renal replacement therapy * coronary artery disease (any stage) * chronic heart failure (New York Heart Association Functional Classifcation ≥ II) * valvular heart disease (moderate or severe); * history of stroke * peripheral arterial occlusive disease (any stage) * chronic obstructive pulmonary disease (any stage) or pulmonary fibrosis (any stage) * diabetes mellitus requiring oral hypoglycemic agent or insulin; immunodeficiency due to a disease (e.g., HIV, leukemia, multiple myeloma, solid organ cancer) or therapy (e.g., immunosuppressants, chemotherapy, radiation, steroids) * liver cirrhosis (any Child-Pugh class) \-- body mass index ≥30 kg/m2 * current smoking or 15 pack-year history of smoking * All participants must receive clear study information and give signed informed consent Exclusion Criteria: * Patients with preoperative cardiac arrhythmias (atrial fibrillation) as the monitoring devices are not accurate under cardiac arrhythmias. * No affiliation with the French health care system * Patients participating in another randomized controlled trial with the same clinical endpoint, or interventions possibly compromising the primary outcome. * Pregnant patients * Patient on AME (state medical aid) (unless exemption from affiliation) * Patients guardianship/legal protection/curatorship
Where this trial is running
Irvine, California and 16 other locations
- University of California IRVINE — Irvine, California, United States (Recruiting)
- University of California Los Angeles (UCLA) — Los Angeles, California, United States (Recruiting)
- UZ Brussels — Brussels, Brussels Capital, Belgium (Recruiting)
- CHUM Montreal — Montreal, Montreal, Canada (Recruiting)
- Chu Dijon — Dijon, Dijon, France (Recruiting)
- ALEXANDRE JOOSTEN, MD PhD — Le Kremlin-Bicêtre, France, France (Recruiting)
- Chu Grenoble Alpes — Grenoble, Grenoble, France (Recruiting)
- Centre chirurgical Marie Lannelongue — Le Plessis-Robinson, Haut de Seine, France (Recruiting)
- Bicetre — Le Kremlin-Bicêtre, Paris, France (Recruiting)
- Beaujon — Paris, Paris, France (Recruiting)
- Hegp — Paris, Paris, France (Recruiting)
- Insititut Mutualiste Montsouris — Paris, Paris, France (Recruiting)
- La Pitie Salpetriere — Paris, Paris, France (Recruiting)
- Chu Toulouse — Toulouse, Toulouse, France (Recruiting)
- Chu Lille — Lille, France (Recruiting)
- Centre hospitalier universitaire de NANCY — Nancy, France (Recruiting)
- University Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: ALEXANDRE JOOSTEN, MD PhD
- Email: joosten-alexandre@hotmail.com
- Phone: +33145213441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.