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Clinical Trials in Mexico / NCT07658001
Active, not recruiting Observational

Fecal Lactate and Resuscitation Outcomes in Critical Illness

NCT07658001 · tracked via the Priya Life Science Mexico tracker
Sponsor
Hospital H+ Queretaro
Phase
Observational
Started
2026-04-06
Last updated
2026-07-29

Condition(s) studied

Tissue HypoperfusionCritical IllnessShockSepsis

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Poor Response to Resuscitation at 24 Hours — 24 hours
    Composite outcome defined by the presence of at least one of the following within 24 hours: increase in vasopressor requirements compared to baseline, serum lactate clearance \<10% or persistent lactate \>2 mmol/L, increase in SOFA score ≥1 point, or death.

Trial sites (1)

FacilityCityRegionStatus
Hospital H+ Querétaro Querétaro City Querétaro

More Hospital H+ Queretaro trials in Mexico

Standardization of IMT Dosage (UTIT) in Mechanical Ventilation. Enrolling by invitation
Ultrasound vs. Nasofibroscopy for Evaluating Dysphagia After Extubation in the ICU Recruiting

Other trials for the same condition

Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial Active, not recruiting
Volume Removal Intolerance During Net Ultrafiltration in Acute Kidney Injury Patients Recruiting
Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver Recruiting
The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients Recruiting
Curcumin in Critically Ill Patients With Sepsis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07658001 on ClinicalTrials.gov ↗ ← All trials in Mexico