Fecal Lactate and Resuscitation Outcomes in Critical Illness

NCT07658001 | Active Not Recruiting

• 1 other identifier: CEI2026-03/01/V1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tissue Hypoperfusion; Critical Illness; Shock; Sepsis

Keywords

Fecal Lactate; Lactate Gradient; Splanchnic Hypoperfusion; Intensive Care Unit; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Poor Response to Resuscitation at 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.

  24 hours

Secondary Outcomes (2)

• Correlation Between Fecal Lactate and Organ Dysfunction

  Baseline and 24 hours

• Diagnostic Performance of Fecal Lactate for Predicting Poor Response

  24 hours

Study Arms (1)

Critically Ill Patients with Tissue Hypoperfusion

Single cohort of adult critically ill patients admitted to the intensive care unit with evidence of tissue hypoperfusion. Fecal and serum lactate levels are measured within the first 12-24 hours. No interventions are assigned, and patients are managed according to standard of care. The study evaluates the prognostic value of fecal lactate and the fecal-to-serum lactate gradient in predicting response to resuscitation at 24 hours.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital H+ Queretaro: lead

Study Sites (1)

Hospital H+ Querétaro

Querétaro City, Querétaro, 76000, Mexico

Location

Related Publications (5)

• Wang R, Wen C, Lei Q, Zeng S. Lactate regulation may be a key factor in the protection of the intestinal barrier in sepsis under high-altitude hypoxic and hypobaric conditions. Crit Care. 2025 Dec 8;29(1):520. doi: 10.1186/s13054-025-05793-x. No abstract available.

  PMID: 41361463 BACKGROUND

• Liu S, Yang T, Jiang Q, Zhang L, Shi X, Liu X, Li X. Lactate and Lactylation in Sepsis: A Comprehensive Review. J Inflamm Res. 2024 Jul 8;17:4405-4417. doi: 10.2147/JIR.S459185. eCollection 2024.

  PMID: 39006496 BACKGROUND

• Baldeon AD, Holthaus TA, Khan NA, Holscher HD. Fecal Microbiota and Metabolites Predict Metabolic Health Features across Various Dietary Patterns in Adults. J Nutr. 2025 Jun;155(6):1795-1803. doi: 10.1016/j.tjnut.2025.03.024. Epub 2025 Mar 22.

  PMID: 40122388 BACKGROUND

• Zhang S, Luo M, Lu Z, Shi Q. Lactate and lactylation in sepsis-associated acute kidney injury: clinical evidence from the MIMIC-IV database and mechanistic insights. Front Med (Lausanne). 2025 Nov 14;12:1708145. doi: 10.3389/fmed.2025.1708145. eCollection 2025.

  PMID: 41322213 BACKGROUND

• Fuller BM, Dellinger RP. Lactate as a hemodynamic marker in the critically ill. Curr Opin Crit Care. 2012 Jun;18(3):267-72. doi: 10.1097/MCC.0b013e3283532b8a.

  PMID: 22517402 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal samples collected within the first 12-24 hours of ICU admission. Samples are processed through dilution, homogenization, and centrifugation to obtain a supernatant ("fecal water"), which is analyzed using a colorimetric assay for L-lactate measurement. No genetic or DNA analysis will be performed.

MeSH Terms

Conditions

Critical Illness; Shock; Sepsis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

ME (1)