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Stool sample may predict survival in ICU patients

NCT ID NCT07658001

Knowledge-focused Sponsor: Hospital H+ Queretaro Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Updated 2 times

Summary

This study looks at whether measuring lactate in stool can help doctors predict how well critically ill patients with low blood flow will respond to treatment. About 40 adults in the ICU will provide a stool sample within 24 hours of admission. Researchers will check if high stool lactate levels are linked to worse outcomes, such as needing more medication or organ failure. The goal is to find a simple, noninvasive way to guide care early on.

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 40 people

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

Started

Apr 2026

Expected to finish

Dec 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.

Who is studied

Adult critically ill patients admitted to the intensive care unit with evidence of tissue hypoperfusion. Patients are identified at ICU admission or within the first 24 hours of shock onset and must have availability of a fecal sample for analysis. All patients receive standard of care management according to institutional protocols, and no interventions are assigned as part of the study.

Ages

18 to 100 years

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: * Adult patients ≥18 years admitted to the intensive care unit (ICU) * Evidence of tissue hypoperfusion defined by at least ONE of the following: Arterial serum lactate ≥2.0 mmol/L or Hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥65 mmHg * Clinical signs of hypoperfusion (capillary refill time \>3 seconds or mottling score ≥2) * Availability of fecal sample within the first 24 hours of ICU admission Exclusion Criteria: * Active gastrointestinal bleeding * Recent abdominal surgery (\<48 hours) with intestinal resection or stoma * Confirmed Clostridioides difficile infection * Do-not-resuscitate (DNR) orders at ICU admission

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Conditions

The condition(s) this trial relates to.

Critical Illness infectious disease with sepsis ischemic disease Sepsis Shock

As listed by the trial registrant

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

Critical illness Sepsis Shock Tissue hypoperfusion

Contacts and locations

Locations

  • Hospital H+ Querétaro

    Querétaro City, Querétaro, 76000, Mexico

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