"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
Trial ID: NCT06011187
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-02-01
Completion date: 2026-12-30
Sponsor: Assistance Publique - Hôpitaux de Paris
Conditions: Decision Support System; Outcome
Interventions: Routine care; AFM
Locations: University of California IRVINE; University of California Los Angeles (UCLA); UZ Brussels; CHUM Montreal; Chu Dijon; ALEXANDRE JOOSTEN, MD PhD; Chu Grenoble Alpes; Centre chirurgical Marie Lannelongue; BICETRE; BEAUJON; HEGP; Insititut Mutualiste Montsouris; La Pitie Salpetriere; Chu Toulouse; Chu Lille; Centre hospitalier universitaire de NANCY; University Medical Center Hamburg-Eppendorf
Countries: United States; United States; Belgium; Canada; France; France; France; France; France; France; France; France; France; France; France; France; Germany
Enrollment: 2000
Age range: 18 Years - None
Sex: ALL

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.

Eligibility 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

Outcomes:
Composite endpoint ("any event versus none") of major postoperative complications within 30 days after surgery