Outcome Clinical Trial
— PEFLAOfficial 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
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | December 30, 2026 |
Est. primary completion date | May 2, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Brussels | Brussel | |
Canada | CHUM Montreal | Montréal | Montreal |
France | CHU Clermont-Ferrand | Clermont-Ferrand | |
France | Chu Dijon | Dijon | |
France | ALEXANDRE JOOSTEN, MD PhD | Le Kremlin-Bicêtre | |
France | BICETRE | Le Kremlin-Bicêtre | Paris |
France | Centre chirurgical Marie Lannelongue | Le Plessis-Robinson | Haut De Seine |
France | Chu Lille | Lille | |
France | Centre hospitalier universitaire de NANCY | Nancy | |
France | BEAUJON | Paris | |
France | HEGP | Paris | |
France | Insititut Mutualiste Montsouris | Paris | |
France | La Pitie Salpetriere | Paris | |
France | Chu Toulouse | Toulouse | |
Germany | University Medical Center Hamburg-Eppendorf | Hamburg | |
United States | University of California IRVINE | Irvine | California |
United States | University of California Los Angeles (UCLA) | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
United States, Belgium, Canada, France, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite endpoint ("any event versus none") of major postoperative complications within 30 days after surgery | It includes : acute myocardial injury, including myocardial infarction, acute kidney injury, severe infectious complications (including deep surgical site infection, pneumonia, sepsis, peritonitis), anastomotic leakage, pulmonary embolism or venous thrombosis, pulmonary edema, acute respiratory distress syndrome, de novo arrhythmia, stroke, reoperation for any cause, non-fatal cardiac arrest, and mortality within 30 days after surgery | Postoperative day 30 | |
Secondary | Incidence of each of the individual components of the composite primary outcome within 30 days after surgery | Postoperative day 30 | ||
Secondary | Incidence of the composite primary outcome within 7 days after surgery | Postoperative day 7 | ||
Secondary | Incidence of a composite of postoperative infection rate within 30-day of surgery. | This is defined as one or more of the following infections: surgical site infection, organ space surgical-site infection, urinary tract infection, laboratory-confirmed blood stream infection or infection, source uncertain (this is defined as an infection which could be more than one of the above but it is unclear which) | Postoperative day 30 | |
Secondary | Clavien-dindo classification score | Postoperative day 30 | ||
Secondary | Comprehensive complication index (CCI) | Postoperative day 30 | ||
Secondary | Length of stay in the hospital | Postoperative day 30 | ||
Secondary | Incidence of unplanned hospital re-admission within 30 days after surgery | Postoperative day 30 | ||
Secondary | Mortality rate at 90 days after surgery. | Postoperative day 90 |
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