Fecal Lactate and Resuscitation Outcomes in Critical Illness (NCT07658001) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Fecal Lactate and Resuscitation Outcomes in Critical Illness
Mexico40 participantsStarted 2026-04-06
Plain-language summary
This study evaluates the prognostic value of fecal lactate and the fecal-to-serum lactate gradient as early biomarkers of tissue hypoperfusion in critically ill patients. While serum lactate is widely used, it may not accurately reflect splanchnic perfusion. This prospective observational study aims to determine whether fecal lactate levels obtained within the first 12-24 hours can predict poor response to resuscitation at 24 hours. The primary outcome is a composite of increased vasopressor requirements, persistent hyperlactatemia, worsening organ dysfunction, or death.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying fecal lactate as a way to predict poor response to resuscitation in critically ill patients with conditions like sepsis and shock — can you explain what fecal lactate actually measures and whether tracking it might change how my care team makes decisions in my specific case?
2Since this study is observational and focused on measuring outcomes rather than testing a new treatment, does participating mean my actual resuscitation care would stay the same as standard treatment, or could it affect any decisions made in those first 24 hours?
3The trial is no longer actively recruiting new participants — does that mean results might be available soon, and could those findings influence how my team monitors and manages my resuscitation right now?
4Given that this trial involves critical illness and shock, what does 'poor response to resuscitation at 24 hours' actually mean in practice, and how does my team currently assess whether I'm responding well enough to treatment?
5Are there existing tools or markers my care team is already using to track how I'm responding to resuscitation, and how might the fecal lactate approach being studied here compare to what's already being done for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.