Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT06011187 En recrutement IDF

Titre

"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

Type

Interventional

Pathologie

Phase

N/A

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

février 2024

Date de fin

décembre 2026

Dernière mise à jour

15 septembre 2025

Résumé

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.

Détail

Voir le détail 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 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. Even under ideal study conditions, strict adherence to GDFT protocols is hampered by the workload and concentration required for consistent implementation. Hemodynamic monitors and protocols alone do not enable optimal fluid titration to be provided consistently to all patients - there must also be appropriate and timely interpretation and intervention. To address this problem of consistency and protocol adherence, a decision support system, "Assisted Fluid Management" (AFM), has been developed to help ease some of the work associated with GDFT protocol implementation. The AFM system (released on the European market in March 2017) 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. This system was recently implemented in a before-and-after study in a Belgian academic hospital, where the authors reported that the implementation of this AFM software system allowed a better adherence to the GDFT algorithm. However, as this was a pilot study with a small number of patients, the study was not powered to demonstrate a beneficial effect on the incidence of postoperative complications. More recently, a group from the Cleveland Clinic demonstrated that using AFM system resulted in more boluses being effective when compared to the administration of boluses without AFM support. There are no randomized controlled studies to date comparing this AFM system to standard of care on patient outcome. We therefore aim to conduct a multicenter stepped-wedge, cluster-randomized trial involving patients undergoing high risk abdominal surgery to compare a GDFT strategy guided by the AFM system with usual care. A stepped wedge, cluster-randomized trial approach was chosen in which clusters will be randomized to commence the intervention at different times following an initial control period in which outcomes will be measured for usual care. So, each center (cluster) began in the control phase and transitioned to the intervention phase at a randomly assigned time (wedge). The order in which each center will move from control to intervention phase will be randomly allocated by a computer algorithm performed by the study statistician. We selected cluster randomization rather than randomization of individual patients because the control group could be very different among centers (from GDFT strategy using a flow monitoring to GDFT with a written protocol to no clear strategy (use of an arterial line only without any advanced monitoring). Interestingly, this approach also decreases the Hawthorne effect which has been shown to decrease the incidence rate of the primary outcome in recent randomized trials because clinicians know that their patients are included in a research protocol. Fermer le détail

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	En recrutement IDF	18/09/2025 17:34:43	Contacter
INSTITUT MUTUALISTE MONTSOURIS	ROULLET Stéphanie	En recrutement IDF	18/09/2025 17:34:43	Contacter
AP-HP Assistance publique - Hôpitaux de Paris		En recrutement IDF	18/09/2025 17:34:43	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 hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
			18/09/2025 17:34:42	Contact (sur clinicalTrials)
			18/09/2025 17:34:42	Contact (sur clinicalTrials)
			18/09/2025 17:34:43	Contact (sur clinicalTrials)
			18/09/2025 17:34:43	Contact (sur clinicalTrials)
			18/09/2025 17:34:43	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
ALEXANDRE JOOSTEN, MD PhD - 94200 - Le Kremlin-Bicêtre - France		En recrutement		Contact (sur clinicalTrials)
Centre chirurgical Marie Lannelongue - Le Plessis-Robinson - Haut De Seine - France		En recrutement		Contact (sur clinicalTrials)
Centre hospitalier universitaire de NANCY - Nancy - France		En recrutement		Contact (sur clinicalTrials)
Chu Dijon - Dijon - France	Pierre grefoire GUINOT, MD PhD	En recrutement		Contact (sur clinicalTrials)
Chu Grenoble Alpes - Grenoble - France		En recrutement		Contact (sur clinicalTrials)
Chu Lille - Lille - France		En recrutement		Contact (sur clinicalTrials)
Chu Toulouse - Toulouse - France		En recrutement		Contact (sur clinicalTrials)
HEGP - Paris - France		En recrutement		Contact (sur clinicalTrials)
Insititut Mutualiste Montsouris - Paris - France		En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT06011187 - "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

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