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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDirection Centrale du Service de Santé des Armées

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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);

Trial population

hosptalized adults in ICU, France.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • enteric dyed solution

    Dietary supplement

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

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: patients with mono-organ failure1 intervention
Group B: patients with multi-visceral failure1 intervention

Trial outcomes

Primary outcomes

1

intestinal failure and survival 90 days post inclusion

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

Time frame
2024-2027

Secondary outcomes

1

intestinal permeability as a function of organ failure

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

Time frame
2024-2027

Other outcomes

Sponsors and contacts

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