Status:
RECRUITING
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Decision Support System
Outcome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 go...
Detailed Description
Many trials have indicated that goal-directed fluid therapy (GDFT) strategies or more recently "personalized fluid therapy" may benefit high-risk surgical patients but these strategies are infrequentl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06011187
Start Date
February 1 2024
End Date
December 30 2026
Last Update
September 8 2025
Active Locations (17)
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1
University of California IRVINE
Irvine, California, United States, 92868
2
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
3
UZ Brussels
Brussels, Brussels Capital, Belgium
4
CHUM Montreal
Montreal, Montreal, Canada