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

NCT06845865 | Recruiting

• 2 other identifiers: 2021PPRC022023-A02005-40
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Multivisceral Failure Syndrome; Monovisceral Failure; Infection in ICU

Outcome Measures

Primary Outcomes (1)

• intestinal failure and survival 90 days post inclusion

  Evaluation of the impact of changes in permeability (classified into 3 categories: absent, moderately increased, and highly increased) on patient survival at day 90

  2024-2027

Secondary Outcomes (1)

• intestinal permeability as a function of organ failure

  2024-2027

Study Arms (2)

patients with mono-organ failure

20 \< SAPS2 \< 40

Dietary Supplement: enteric dyed solution

patients with multi-visceral failure

60 \< SAPS2 \< 80

Dietary Supplement: enteric dyed solution

Interventions

enteric dyed solution DIETARY_SUPPLEMENT

Oral administration of 0.5 mg/kg of body weight of food coloring dye

patients with mono-organ failure; patients with multi-visceral failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hosptalized adults in ICU, France.

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.

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead
• Centre Borelli UMR 9010: collaborator

Study Sites (1)

Hopital Bégin

Vincennes, France

RECRUITING

Related Publications (5)

• Angarita SAK, Duarte S, Russell TA, Ruchala P, Elliott IA, Whitelegge JP, Zarrinpar A. Quantitative Measure of Intestinal Permeability Using Blue Food Coloring. J Surg Res. 2019 Jan;233:20-25. doi: 10.1016/j.jss.2018.07.005. Epub 2018 Jul 27.

  PMID: 30502249 BACKGROUND

• Dambroise E, Monnier L, Ruisheng L, Aguilaniu H, Joly JS, Tricoire H, Rera M. Two phases of aging separated by the Smurf transition as a public path to death. Sci Rep. 2016 Mar 22;6:23523. doi: 10.1038/srep23523.

  PMID: 27002861 BACKGROUND

• Doig CJ, Sutherland LR, Sandham JD, Fick GH, Verhoef M, Meddings JB. Increased intestinal permeability is associated with the development of multiple organ dysfunction syndrome in critically ill ICU patients. Am J Respir Crit Care Med. 1998 Aug;158(2):444-51. doi: 10.1164/ajrccm.158.2.9710092.

  PMID: 9700119 BACKGROUND

• Gayat E, Cariou A, Deye N, Vieillard-Baron A, Jaber S, Damoisel C, Lu Q, Monnet X, Rennuit I, Azoulay E, Leone M, Oueslati H, Guidet B, Friedman D, Tesniere A, Sonneville R, Montravers P, Pili-Floury S, Lefrant JY, Duranteau J, Laterre PF, Brechot N, Chevreul K, Michel M, Cholley B, Legrand M, Launay JM, Vicaut E, Singer M, Resche-Rigon M, Mebazaa A. Determinants of long-term outcome in ICU survivors: results from the FROG-ICU study. Crit Care. 2018 Jan 18;22(1):8. doi: 10.1186/s13054-017-1922-8.

  PMID: 29347987 BACKGROUND

• Harris CE, Griffiths RD, Freestone N, Billington D, Atherton ST, Macmillan RR. Intestinal permeability in the critically ill. Intensive Care Med. 1992;18(1):38-41. doi: 10.1007/BF01706424.

  PMID: 1578045 BACKGROUND

Study Officials

• Clément DUBOST, MD, PhD

  National teaching army hospital BEGIN (Hôpital National d'Instruction des Armées BEGIN)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael RERA, PhD

CONTACT

+33781945974; michael.rera@cnrs.fr

Rachel HAUS, PhD

CONTACT

evdg-dpar.contact.fct@intradef.gouv.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 25, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 2, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)