Fecal Lactate and Resuscitation Outcomes in Critical Illness (DELTA-LAC)
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Querétaro
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Querétaro City, Querétaro, México, 76000
- Hospital H+ Queretaro
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Poor Response to Resuscitation at 24 Hours
Periodo de tiempo: 24 hours
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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.
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24 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Correlation Between Fecal Lactate and Organ Dysfunction
Periodo de tiempo: Baseline and 24 hours
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Assessment of the association between fecal lactate levels and the severity of organ dysfunction measured by SOFA score at baseline and 24 hours.
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Baseline and 24 hours
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Diagnostic Performance of Fecal Lactate for Predicting Poor Response
Periodo de tiempo: 24 hours
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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).
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24 hours
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Términos relacionados con este estudio
Palabras clave
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Otros números de identificación del estudio
- CEI2026-03/01/V1
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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