Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new system called the Assisted Fluid Management (AFM) system, which aims to improve how fluids are given to high-risk patients after they undergo major abdominal surgery. The goal of this system is to help healthcare providers decide the right amount of fluids to administer, which can lead to better recovery outcomes and fewer complications after surgery. The AFM system uses artificial intelligence to suggest fluid doses and continuously monitors the patient's response to ensure they are receiving the appropriate care.

To be eligible for this trial, participants must be adults aged 18 or older who are scheduled for elective high-risk abdominal surgery. They should also meet certain health criteria, such as having existing heart or lung conditions, diabetes, or being significantly overweight. Those who are pregnant, have certain heart issues, or are involved in other related clinical trials cannot participate. If you join the study, you will receive detailed information about what to expect, and you'll need to give your consent to participate. This trial is important because it could lead to better treatment strategies for patients who are at a higher risk during and after surgery.

Gender

ALL

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