Tissue HypoperfusionDELTA-LACNCT07658001
Fecal Lactate and Resuscitation Outcomes in Critical Illness
An observational study of Tissue Hypoperfusion and Critical Illness, run by Hospital H+ Queretaro at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tissue Hypoperfusion, Critical Illness, Shock
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 6 Apr 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tissue Hypoperfusion, Critical Illness, Shock, Sepsis
- Keywords
- Fecal Lactate, Lactate Gradient, Splanchnic Hypoperfusion, Intensive Care Unit, Biomarkers
- Medical subject headings
- Critical Illness, Shock, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
Correlation Between Fecal Lactate and Organ Dysfunction
Assessment of the association between fecal lactate levels and the severity of organ dysfunction measured by SOFA score at baseline and 24 hours.
Measured: Baseline and 24 hours
Diagnostic Performance of Fecal Lactate for Predicting Poor Response
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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start6 Apr 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tissue HypoperfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658001
- Sponsor's protocol ID
- CEI2026-03/01/V1
- Acronym
- DELTA-LAC
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 41361463Liu 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.
PubMed 39006496Baldeon 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.
PubMed 40122388Zhang 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.
PubMed 41322213Fuller 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.
PubMed 22517402
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07658001
- Acronym / sponsor ID
- DELTA-LAC / CEI2026-03/01/V1
- Conditions
- Tissue Hypoperfusion, Critical Illness, Shock, Sepsis
- Keywords
- Fecal Lactate, Lactate Gradient, Splanchnic Hypoperfusion, Intensive Care Unit, Biomarkers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Correlation Between Fecal Lactate and Organ Dysfunction
Time frame: Baseline and 24 hours
Diagnostic Performance of Fecal Lactate for Predicting Poor Response
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 41361463Wang 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.
- Background: PubMed 39006496Liu 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.
- Background: PubMed 40122388Baldeon 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.
- Background: PubMed 41322213Zhang 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.
- Background: PubMed 22517402Fuller 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tissue Hypoperfusion and Critical Illness, run by Hospital H+ Queretaro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor Response to Resuscitation at 24 Hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07658001, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.