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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
enteric dyed solution
Dietary supplementOral administration of 0.5 mg/kg of body weight of food coloring dye
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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)
Sponsors and contacts
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Direction Centrale du Service de Santé des Armées
Lead sponsor
Centre Borelli UMR 9010
Collaborator