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Gut feeling could save lives: new score may improve ICU death predictions

NCT ID NCT07586254

Knowledge-focused Sponsor: Ozkul Yilmaz Colak 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether adding a measure of gut function to a standard organ failure score can better predict which critically ill patients are at highest risk of dying. Researchers will follow 800 adults in Turkish ICUs, using only routine data—no extra tests or treatments. The goal is to improve how doctors assess risk and make decisions in the intensive care unit.

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.

Participants

About 800 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

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.

Who is studied

Adult patients (≥18 years) consecutively admitted to participating tertiary intensive care units in Türkiye. The study population includes both medical and surgical ICU admissions, with a broad mix of admission diagnoses representative of contemporary critical care practice. Patients will be enrolled regardless of underlying disease, as long as they meet eligibility criteria within the first 24 hours of ICU admission.

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: * Adults aged 18 years or older * Admission to a participating intensive care unit * Expected ICU length of stay of at least 24 hours * Availability of clinical and laboratory data required to calculate the SOFA2 score and the AGI grade within the first 24 hours of ICU admission * Written informed consent obtained from the patient or, when not feasible due to the patient's clinical condition, from a legally authorized representative Exclusion Criteria: * Age younger than 18 years * Pregnancy * ICU length of stay shorter than 24 hours (including patients who die or are discharged within the first 24 hours) * ICU readmission during the same hospital stay (only the index admission will be included) * Postoperative admission for routine monitoring without organ dysfunction (planned short-term observation following elective surgery) * Admission solely for end-of-life care or with treatment limitations (do-not-resuscitate or withdrawal of life-sustaining therapy decisions) made within the first 24 hours of admission * Patients with primary gastrointestinal pathology as the reason for ICU admission that would confound AGI grading (e.g., gastrointestinal surgery within the preceding 7 days, acute mesenteric ischemia as the primary diagnosis) * Patients with anatomical or functional conditions precluding standard AGI assessment (e.g., short bowel syndrome, permanent gastrostomy/jejunostomy with chronic feeding intolerance, chronic intestinal pseudo-obstruction) * Refusal of consent by the patient or legal representative * Participation in an interventional clinical trial that may affect outcome measures

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Conditions

The condition(s) this trial relates to.

Critical Illness digestive system disorder multiple organ dysfunction syndrome

As listed by the trial registrant

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

Critical illness Gastrointestinal diseases Mortality Multiple organ failure

How to take part

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

  1. The places running it

    1 site. 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

  • Ondokuz Mayis University

    Samsun, Atakum, 55002, Turkey (Türkiye)

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