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Artificial intelligence may help surgeons manage fluids better during major abdominal operations

NCT ID NCT06871150

Disease control Sponsor: ASST Sette Laghi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether artificial intelligence can help doctors give the right amount of fluids during major abdominal cancer surgery. 150 patients aged 65 or older will be randomly assigned to one of three fluid management protocols, all using AI tools. The goal is to see if AI-guided care reduces complications like kidney injury and shortens hospital stays.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Flotrac sensor and AI software (Hypotension Prediction Index, Assisted Fluid Management)
What this could lead to
If successful, this could lead to a standard method for giving fluids during major abdominal surgery, reducing complications like kidney injury and shortening hospital stays.
What could go wrong
This is a small, early-stage trial (150 patients) comparing different monitoring strategies, not testing a new drug. The AI tools may not significantly improve outcomes over standard care.

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

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

65 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: * Age ≥ 65 years. * ASA physical status II-III-IV. * Patients undergoing elective major abdominal oncological surgery. * Revised Cardiac Index Score ≥ 2. * Plan to perform the procedure with invasive arterial monitoring. * Expected surgical time greater than 120 minutes. Exclusion Criteria: * Emergency or urgent surgeries. * Severe chronic renal failure (creatinine clearance \< 30 ml/min). * Chronic heart failure (NYHA Class IV). * Pregnant women. * Contraindications to pulse contour hemodynamic monitoring. * Liver surgery. * Patient refusal.

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As listed by the trial registrant

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

Hemodynamic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII

    RECRUITING

    Bergamo, Italy, 24127, Italy

  • Humanitas Research Hospital

    RECRUITING

    Rozzano, Italy, 20089, Italy

  • University Hospital Varese ASST SetteLaghi

    RECRUITING

    Varese, Italy, 21100, Italy

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