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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-20

Study Completion Date

2029-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Multivisceral Failure Syndrome Monovisceral Failure Infection in ICU

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with mono-organ failure

20 \< SAPS2 \< 40

enteric dyed solution

Intervention Type DIETARY_SUPPLEMENT

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

patients with multi-visceral failure

60 \< SAPS2 \< 80

enteric dyed solution

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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enteric dyed solution

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No