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NCT Number: NCT06845865

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 tube whose 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 swallow or with a nasogastric tube whose indication was determined independently of the study's needs).

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 a nasogastric 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 or between 40 and 60 or > 80.

Treatment and study plan

enteric dyed solution

Dietary Supplement

Oral administration of 0.5 mg/kg of body weight of food coloring dye

Primary outcomes

  1. intestinal failure and survival 90 days post inclusion

    Time frame: 2024-2027

    Evaluation of the impact of changes in permeability (classified into 3 categories: absent, moderately increased, and highly increased) on patient survival at day 90

Secondary outcomes

  1. intestinal permeability as a function of organ failure

    Time frame: 2024-2027

    Comparison of average intestinal permeability between patients with a single organ failure versus multiple organ failures on day 1 in the blood (plasma)

Study contacts

Contact information is provided by the study sponsor or research team.

Michael RERA, PhD

CONTACT

[email protected]

+33781945974

Rachel HAUS, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Collaborators

  • Centre Borelli UMR 9010

Registry information

Acronym: BLUE-REA

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 25, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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