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

27 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

40

Kontakter och platser

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Studieorter

  • Mexiko
    • Querétaro
      • Querétaro City, Querétaro, Mexiko, 76000
        • Hospital H+ Queretaro

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Poor Response to Resuscitation at 24 Hours
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Correlation Between Fecal Lactate and Organ Dysfunction
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Hospital H+ Queretaro

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 april 2026

Primärt slutförande (Beräknad)

1 november 2026

Avslutad studie (Beräknad)

1 december 2026

Studieregistreringsdatum

Först inskickad

15 juni 2026

Först inskickad som uppfyllde QC-kriterierna

15 juni 2026

Första postat (Faktisk)

18 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CEI2026-03/01/V1

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

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Nej

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