Fecal Lactate and Resuscitation Outcomes in Critical Illness (DELTA-LAC)

July 27, 2026 updated by: Jose J Zaragoza, MD MSc, Hospital H+ Queretaro

Prognostic Value of Fecal Lactate and the Fecal-to-Serum Lactate Gradient in Resuscitation Response Among Critically Ill Patients With Tissue Hypoperfusion: A Prospective Pilot Study.

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Tissue hypoperfusion is a central mechanism in the development of organ dysfunction in critically ill patients. Although serum lactate is commonly used as a marker of hypoxia and a target for resuscitation, it may not adequately reflect regional perfusion, particularly in the splanchnic circulation. Persistent splanchnic hypoperfusion contributes to intestinal barrier dysfunction, bacterial translocation, and progression to multiple organ failure.

This study is based on the hypothesis that, under ischemic conditions, the intestinal mucosa behaves as a semipermeable membrane, allowing equilibration of lactate produced in the intestinal wall into the lumen. Therefore, fecal lactate may serve as a direct and early marker of intestinal hypoperfusion.

This is a prospective, observational, single-center cohort study conducted in an intensive care unit. Adult patients (≥18 years) with evidence of tissue hypoperfusion will be included. Fecal samples will be collected within the first 12-24 hours and processed through dilution, homogenization, centrifugation, and colorimetric analysis of the supernatant to quantify L-lactate levels. Simultaneously, serum lactate will be measured, and the fecal-to-serum lactate gradient will be calculated.

The primary outcome is poor response to resuscitation at 24 hours, defined as a composite endpoint including increased vasopressor requirements, serum lactate clearance <10% or persistent lactate >2 mmol/L, worsening organ dysfunction measured by SOFA score (increase ≥1 point), or death.

Secondary objectives include evaluating the correlation between fecal lactate and organ dysfunction severity, as well as determining the optimal cut-off value for fecal lactate to predict adverse outcomes using receiver operating characteristic (ROC) curve analysis.

This study aims to identify fecal lactate as a non-invasive, early, and specific biomarker of splanchnic hypoperfusion, potentially improving clinical decision-making and guiding resuscitation strategies in critically ill patients.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Mexico
- Querétaro
  - Querétaro City, Querétaro, Mexico, 76000
    - Hospital H+ Queretaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Poor Response to Resuscitation at 24 Hours Time Frame: 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between Fecal Lactate and Organ Dysfunction Time Frame: Baseline and 24 hours	Assessment of the association between fecal lactate levels and the severity of organ dysfunction measured by SOFA score at baseline and 24 hours.	Baseline and 24 hours
Diagnostic Performance of Fecal Lactate for Predicting Poor Response Time Frame: 24 hours	Evaluation of the predictive accuracy of fecal lactate levels for poor response to resuscitation using receiver operating characteristic (ROC) curve analysis and area under the curve (AUC).	24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital H+ Queretaro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CEI2026-03/01/V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sharing plans are currently undecided. Individual participant data may be shared in the future upon reasonable request, after study completion and publication of results, in accordance with institutional policies and ethical regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.