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

NCT06011187 | Recruiting DMC FDA Device

• 1 other identifier: APHP220817
• Study Type: interventional
• Target: 2,000
• Locations: 5 countries
• Sites: 17

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 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.

Conditions

Decision Support System; Outcome

Keywords

hemodynamic; fluid administration; postoperative complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence of each of the individual components of the composite primary outcome within 30 days after surgery

  Postoperative day 30

• Incidence of the composite primary outcome within 7 days after surgery

  Postoperative day 7

• Incidence of a composite of postoperative infection rate within 30-day of surgery.

  Postoperative day 30

• Clavien-dindo classification score

  Postoperative day 30

• Comprehensive complication index (CCI)

  Postoperative day 30

Study Arms (2)

Routine care

ACTIVE COMPARATOR

During the pre-implementation period, fluid therapy will be done as routine care. Mean arterial pressure (MAP) will be maintained between 65-70 mmHg per standard of care

Procedure: Routine care

Assisted fluid management system

EXPERIMENTAL

In the post-implementation period, fluid bolus administration will be guided by the AFM recommandation. MAP will be maintained between 65-70 mmHg per standard of care

Device: AFM

Interventions

Routine care PROCEDURE

Fluid administration will be given per routine care MAP between 65 - 70 mmHg

Routine care

AFM DEVICE

AFM will recommand fluid bolus administration and MAP will be maintained between 65 and 70 mmHg

Assisted fluid management system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (17)

University of California IRVINE

Irvine, California, 92868, United States

RECRUITING

University of California Los Angeles (UCLA)

Los Angeles, California, 90095, United States

RECRUITING

UZ Brussels

Brussels, Brussels Capital, Belgium

RECRUITING

CHUM Montreal

Montreal, Montreal, Canada

RECRUITING

Chu Dijon

Dijon, Dijon, France

RECRUITING

ALEXANDRE JOOSTEN, MD PhD

Le Kremlin-Bicêtre, France, 94200, France

RECRUITING

Chu Grenoble Alpes

Grenoble, Grenoble, France

RECRUITING

Centre chirurgical Marie Lannelongue

Le Plessis-Robinson, Haut de Seine, France

RECRUITING

BICETRE

Le Kremlin-Bicêtre, Paris, France

RECRUITING

BEAUJON

Paris, Paris, France

RECRUITING

HEGP

Paris, PARIS, France

RECRUITING

Insititut Mutualiste Montsouris

Paris, Paris, France

RECRUITING

La Pitie Salpetriere

Paris, PARIS, France

RECRUITING

Chu Toulouse

Toulouse, Toulouse, France

RECRUITING

Chu Lille

Lille, France

RECRUITING

Centre hospitalier universitaire de NANCY

Nancy, France

RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, Germany

NOT YET RECRUITING

Related Publications (1)

• Coeckelenbergh S, Delaporte A, Rousseleau D, De Montblanc J, Roullet S, Ramadan J, Cholley B, Sitbon A, Weiss E, Kassab MC, Diop S, Manzi E, Pustetto M, Porta Bonette G, Guinot PG, Guerci P, Vanhonacker D, Carrier FM, Alexander B, Rinehart J, Boldt D, Grogan T, Cannesson M, Duranteau J, Grimaldi L, Pereira B, Joosten A. Investigating the effectiveness of an intraoperative decision support guided fluid therapy intervention on postoperative outcome of high-risk patients undergoing high-risk abdominal surgery: protocol for an international multicentre stepped-wedge cluster-randomised implementation trial. BJA Open. 2025 Jun 5;14:100421. doi: 10.1016/j.bjao.2025.100421. eCollection 2025 Jun.

  PMID: 40529718 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ALEXANDRE JOOSTEN, MD PhD

  PAUL BROUSSE HOSPITAL

  STUDY DIRECTOR

Central Study Contacts

ALEXANDRE JOOSTEN, MD PhD

CONTACT

+33145213441; joosten-alexandre@hotmail.com

Jacques DURANTEAU, MD PhD

CONTACT

+33145213441; jacques.duranteau@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded and a data monitoring willbe done on data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster randomized controlled trial

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: February 1, 2024
• Primary Completion: May 2, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-06

Locations

US (2); FR (12); CA (1); BE (1); DE (1)