Prospective Study Evaluating the Prevalence of Intestinal Dysfunction

NCT07022548 | Completed

• 2 other identifiers: 2023/060/OBN° IDRCB : 2023-A00552-43
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The intestinal tract has multiple functions within the body beyond its primary function of nutrient absorption. It acts as a true barrier protecting the body from living microorganisms and antigens in the intestinal lumen. Impairment of any component of the intestinal barrier results in nutrient malabsorption, an altered local digestive immune response, and increased intestinal permeability. The primary function of this barrier is to limit the access of the contents of the intestinal lumen, which particularly includes the bacterial components of the microbiota, to the internal environment and the circulation. This physical barrier function is provided by a monolayer of epithelial cells, closely connected to each other by intercellular junctions (tight junctions, adherens and desmosomes, as well as by the mucus which covers the apical surface of the cells, the constituents of which, mucins, are secreted by the goblet cells. The term intestinal barrier is also used in a broader sense including a protective role against the invasion of environmental pathogens, while allowing toleranSepsis-associated intestinal failure is often underestimated, yet it is found in 20 to 60% of ICU (Intensive Care Unit)vpatients. However, its prognosis is poorly documented. For example, there is no consensus definition of this dysfunction or validated biomarkers for rapid assessment. Consequently, it does not appear in most prognostic scores (SOFA, IGS2, etc.). Intestinal permeability, a risk factor for bacterial translocation when elevated, is increased in ICU (Intensive Care Unit) patients and associated with multiorgan failure system (MODS), particularly in cases of intestinal fasting. However, there is currently no validated marker of acute intestinal failure in intensive care or intensive care.ce towards commensal flora and foods.

Conditions

Intestinal Inflammation

Keywords

sepsis/septic shock; prevalence

Outcome Measures

Primary Outcomes (1)

• Prevalence of intestinal inflammation

  To assess the prevalence of intestinal inflammation defined by the fecal calprotectin level on admission (\<72 hours) in patients with malignant hematological disease admitted to intensive care for sepsis or septic shock.

  72 hours after enrollment visit

Secondary Outcomes (5)

• Prevalence of intestinal hyperpermeability

  72 hours after enrollment visit

• Prevalence of intestinal hyperpermeability

  72 hours after enrollment visit

• Integrity of intestinal tissue

  72 hours after enrollment visit

• Impact of intestinal dysfunction on the occurrence of digestive intolerance

  month 6

• Impact of intestinal dysfunction on mortality

  month 6

Study Arms (2)

Patient admitted to intensive care for sepsis or septic shock with malignant hematological disease

Patient admitted to intensive care for sepsis or septic shock without malignant hematological diseas

Eligibility Criteria

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

Study Population

40 patients with malignant haemopathy admitted for sepsis or septic shock in intensive care and a control population of 40 patients admitted to intensive care for sepsis or septic shock

You may qualify if:

• Population with hematologic malignancy
• Patients over 18 years of age
• Suffering from hematologic malignancy
• Admitted to intensive care for sepsis or septic shock according to sepsis definition 3:
• Sepsis: organ dysfunction (SOFA \> or = 2) related to a host response to infection
• Septic shock: sepsis with acute circulatory failure and metabolic abnormalities (serum lactate \> 2 mmol/L) and vasopressors
• Patients who have read and understood the information letter and do not object to participating in the study
• Affiliated with or beneficiary of a social security scheme.
• Control population
• \- Patient aged over 18
• Admitted to intensive care for sepsis or septic shock according to the sepsis definition 3:
• Sepsis: organ dysfunction (SOFA \> or = 2) related to a host response to infection
• Septic shock: sepsis with acute circulatory failure and metabolic abnormalities (serum lactate \> 2 mmol/L) and vasopressors
• Patient who has read and understood the information letter and does not object to participating in the study
• Member of or beneficiary of a social security scheme

You may not qualify if:

• For the control group and those with hematologic malignancies:
• Patient refusal
• Pregnant, parturient, or breastfeeding woman
• Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship
• Person who does not understand or speak French
• Moribund
• Limitations of active therapies (LATA) established upon admission
• Hospitalization in intensive care \> 72 hours

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Médecine Intensive Réanimation

Rouen, 76031, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

fecal and blood samples

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Fabienne FT TAMION, Professor

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: November 13, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 1, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)