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

Last updated: April 29, 2025
Sponsor: Direction Centrale du Service de Santé des Armées
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

enteric dyed solution

Clinical Study ID

NCT06845865
2021PPRC02
2023-A02005-40
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patient with single organ failure, secondary to sepsis, hospitalized in intensive care for a foreseeable duration of > 48 hours

  • SAPS2 between 20 and 40 at the sixth hour after the diagnosis of organ failure.

  • Consent from the patient or their trusted person.

  • Affiliation to a social security system.

  • Functional digestive tract and possible feeding (per os or via a nasogastric tubewhose indication was determined independently of the study's needs).

Second group of patients with multi-organ failure:

  • Multi-organ failure syndrome with at least 2 organ failures, secondary to sepsis.

  • SAPS2 between 60 and 80 at the sixth hour after the diagnosis of organ failure.

  • Consent from the patient or their trusted person.

  • Affiliation to a social security system.

  • Functional digestive tract and possible feeding (conscious patient able to swallowor with a nasogastric tube whose indication was determined independently of thestudy's needs).

Exclusion

Exclusion Criteria:

  • Pregnant and breastfeeding women;

  • Minors;

  • Persons under administrative and judicial supervision;

  • Absence of a functional digestive tract (patient unable to swallow and absence of anasogastric tube, contraindication to enteral feeding);

  • Patients with gastroparesis;

  • Refusal of the patient or their trusted person;

  • Patient with a SAPS2 at the sixth hour after the diagnosis of organ failure < 20 orbetween 40 and 60 or > 80.

Study Design

Total Participants: 126
Treatment Group(s): 1
Primary Treatment: enteric dyed solution
Phase:
Study Start date:
February 20, 2025
Estimated Completion Date:
April 30, 2029

Connect with a study center

  • Hopital Bégin

    Vincennes,
    France

    Active - Recruiting

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