NCT06845865 Measurement of Intestinal Permeability in Intensive Care Patients With Single or Multiple Organ Failure
| NCT ID | NCT06845865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Direction Centrale du Service de Santé des Armées |
| Condition | Multivisceral Failure Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 126 participants in total. It began in 2025-02-20 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Clément DUBOST, MD, PhD
PRINCIPAL INVESTIGATOR
National teaching army hospital BEGIN (Hôpital National d'Instruction des Armées BEGIN)
Frequently Asked Questions
Who can join the NCT06845865 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multivisceral Failure Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06845865 currently recruiting?
Yes, NCT06845865 is actively recruiting participants. Contact the research team at michael.rera@cnrs.fr for enrollment information.
Where is the NCT06845865 trial being conducted?
This trial is being conducted at Vincennes, France.
Who is sponsoring the NCT06845865 clinical trial?
NCT06845865 is sponsored by Direction Centrale du Service de Santé des Armées. The principal investigator is Clément DUBOST, MD, PhD at National teaching army hospital BEGIN (Hôpital National d'Instruction des Armées BEGIN). The trial plans to enroll 126 participants.