Measuring gut permeability in ICU patients with organ failure

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

This study is testing how well the gut works in ICU patients with organ failure from sepsis to see if it affects their overall health and recovery.

Quick facts

• Study type: Observational
• Enrollment: 126 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Direction Centrale du Service de Santé des Armées (Academic / other)
• Locations: 1 site (Vincennes)
• Trial ID: NCT06845865 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include ICU patients with single or multiple organ failure secondary to sepsis who have a functional digestive tract.

Not a fit: Patients with organ failure not related to sepsis or those without a functional digestive tract may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of intestinal permeability in critically ill patients, potentially reducing mortality rates.

How similar studies have performed: While studies in animal models have shown a correlation between increased intestinal permeability and mortality, this approach in human patients is novel and has not been extensively tested.

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.

Where this trial is running

Vincennes

• 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

Conditions Multivisceral Failure Syndrome; Monovisceral Failure; Infection in ICU