Actively Recruiting

Age: 18Years +
All Genders
NCT06845865

Measurement of Intestinal Permeability in Intensive Care Patients With Single or Multiple Organ Failure

Led by Direction Centrale du Service de Santé des Armées · Updated on 2025-05-02

126

Participants Needed

1

Research Sites

218 weeks

Total Duration

On this page

Sponsors

D

Direction Centrale du Service de Santé des Armées

Lead Sponsor

C

Centre Borelli UMR 9010

Collaborating Sponsor

AI-Summary

What this Trial Is About

Multivisceral failure syndrome (MVFS) in humans is associated with a very high risk of mortality, ranging between 30 and 50%. This syndrome is associated with significant systemic inflammation and a high risk of bacteremia, the origin of which is not always identified. Among the possible causes of bacteremia, digestive translocation is the most probable but has not been formally proven to date. This translocation is made possible by the numerous cellular and metabolic alterations secondary to MVFS, which can lead to increased intestinal barrier permeability. Intestinal permeability is currently not systematically evaluated in clinical practice in humans. This increased intestinal permeability, associated with the presence of inflammatory markers and a septic state, has been studied in several animal models ranging from the fruit fly (Drosophila) to the mouse. These studies have shown a high risk of mortality associated with increased intestinal permeability. We propose to use this methodology in intensive care patients with at least one organ failure to investigate the link between increased intestinal permeability and survival chances.

CONDITIONS

Official Title

Measurement of Intestinal Permeability in Intensive Care Patients With Single or Multiple Organ Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with single organ failure secondary to sepsis, hospitalized in intensive care expected to stay more than 48 hours
  • SAPS2 score between 20 and 40 at six hours after organ failure diagnosis for single organ failure group
  • Consent given by patient or their trusted person
  • Affiliation to a social security system
  • Functional digestive tract with possible feeding by mouth or nasogastric tube
  • Multi-organ failure syndrome with at least two organ failures secondary to sepsis for multi-organ failure group
  • SAPS2 score between 60 and 80 at six hours after organ failure diagnosis for multi-organ failure group
  • Conscious patient able to swallow or with nasogastric tube for feeding independent of study needs
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Minors
  • Persons under administrative or judicial supervision
  • Absence of a functional digestive tract (unable to swallow and no nasogastric tube or contraindication to enteral feeding)
  • Patients with gastroparesis
  • Refusal of consent by patient or trusted person
  • SAPS2 score less than 20, between 40 and 60, or greater than 80 at six hours after organ failure diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hopital Bégin

Vincennes, France

Actively Recruiting

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Research Team

M

Michael RERA, PhD

CONTACT

R

Rachel HAUS, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Measurement of Intestinal Permeability in Intensive Care Patients With Single or Multiple Organ Failure | DecenTrialz