Measurement of Intestinal Permeability in Intensive Care Patients With Single or Multiple Organ Failure
Recruiting now
Conditions studied: Multivisceral Failure Syndrome, Monovisceral Failure, Infection in ICU
In brief
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.
Key facts
- Study ID
- NCT06845865
- Run by
- Direction Centrale du Service de Santé des Armées
- People needed
- 126
- Starts
- 2025-02-20
- Expected to finish
- 2029-04-30
- Last updated by the study team
- 2025-05-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Hopital Bégin — Vincennes, France (enrolling)
Full record on ClinicalTrials.gov
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