Informations générales (source: ClinicalTrials.gov)
"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
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2024
mars 2026
31 mai 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL MARIE LANNELONGUE | ROULLET Stéphanie | 27/12/2025 07:45:02 | Contacter | ||
| INSTITUT MUTUALISTE MONTSOURIS | ROULLET Stéphanie | 27/12/2025 07:45:02 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 27/12/2025 07:45:02 | Contacter | |||
| AP-HP - Hôpital Beaujon | |||||
| AP-HP - Hôpital Bicêtre | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Paul Brousse | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre chirurgical Marie Lannelongue - Le Plessis-Robinson - Haut De Seine - France | Contact (sur clinicalTrials) | ||||
| Centre hospitalier universitaire de NANCY - Nancy - France | Contact (sur clinicalTrials) | ||||
| Chu Lille - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- 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