Measuring gut permeability in ICU patients with organ failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate intestinal permeability in patients with single or multiple organ failure due to sepsis in an intensive care setting. By using an enteric dyed solution, the study seeks to determine the relationship between increased intestinal permeability and systemic inflammation, which may contribute to high mortality rates associated with multivisceral failure syndrome. The study will include patients who meet specific criteria regarding their organ failure severity and digestive tract functionality. The findings could provide insights into the role of gut health in critically ill patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hopital Bégin
  Vincennes, France Recruiting

Study contacts

• Principal investigator: Clément DUBOST, MD, PhD — National teaching army hospital BEGIN (Hôpital National d'Instruction des Armées BEGIN)
• Study coordinator: Michael RERA, PhD
• Email: michael.rera@cnrs.fr
• Phone: +33781945974

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.