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AI-Guided fluid drips may cut surgery risks in large trial

NCT ID NCT06011187

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an artificial intelligence system that helps doctors decide when to give fluids during high-risk abdominal surgery. The goal was to see if using this smart system could reduce serious complications like kidney injury, infections, or heart problems within 30 days after surgery. About 2007 high-risk adults took part in the study across multiple hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2,007 people

The number who actually took part.

Started

Feb 2024

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Postoperative Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Decision support system Outcome

Contacts and locations

Locations

  • ALEXANDRE JOOSTEN, MD PhD

    Le Kremlin-Bicêtre, France, 94200, France

  • BEAUJON

    Paris, Paris, France

  • BICETRE

    Le Kremlin-Bicêtre, Paris, France

  • CHUM Montreal

    Montreal, Montreal, Canada

  • Centre chirurgical Marie Lannelongue

    Le Plessis-Robinson, Haut de Seine, France

  • Centre hospitalier universitaire de NANCY

    Nancy, France

  • Chu Dijon

    Dijon, Dijon, France

  • Chu Grenoble Alpes

    Grenoble, Grenoble, France

  • Chu Lille

    Lille, France

  • Chu Toulouse

    Toulouse, Toulouse, France

  • HEGP

    Paris, PARIS, France

  • Insititut Mutualiste Montsouris

    Paris, Paris, France

  • La Pitie Salpetriere

    Paris, PARIS, France

  • UZ Brussels

    Brussels, Brussels Capital, Belgium

  • University Medical Center Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, Germany

  • University of California IRVINE

    Irvine, California, 92868, United States

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.