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

Study acronym: BLUE-REA
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Feb 2025 to Feb 2029
    • Start date changed from estimate of Feb 2025 to Feb 20, 2025
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06845865
Lead Sponsor Direction Centrale du Service de Santé des Armées
Collaborators: Centre Borelli UMR 9010
Conditions
(from sponsor)
Multivisceral Failure Syndrome, Monovisceral Failure, Infection in ICU
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov