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RecruitingNCT06845865BLUE-REAUpdated Aug 31, 2026

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

An observational study in Multivisceral Failure Syndrome, Monovisceral Failure and Infection in ICU, sponsored by Direction Centrale du Service de Santé des Armées. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Direction Centrale du Service de Santé des Armées · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
126
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multivisceral Failure Syndrome
  • Monovisceral Failure
  • Infection in ICU
03

In context

Lead sponsor

Direction Centrale du Service de Santé des Armées is the lead sponsor of 95 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

hosptalized adults in ICU, France.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
126 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Dietary supplemententeric dyed solution

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

06

What researchers measure

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

    Time frame: 2024-2027

Secondary outcomes

  1. intestinal permeability as a function of organ failure

    Comparison of average intestinal permeability between patients with a single organ failure versus multiple organ failures on day 1 in the blood (plasma)

    Time frame: 2024-2027

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 30502249 ↗
  • 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. PubMed 27002861 ↗
  • 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. PubMed 9700119 ↗
  • 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. PubMed 29347987 ↗
  • 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. PubMed 1578045 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2025 (actual). Primary completion is estimated for Feb 2029, 48 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2025
First posted
Feb 25, 2025
StartActual
Feb 20, 2025
Primary completionEst.
Feb 2029
CompletionEst.
Apr 30, 2029
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06845865
Lead sponsor
Direction Centrale du Service de Santé des Armées
Collaborators
Centre Borelli UMR 9010
Responsible party
Sponsor
First posted
Feb 25, 2025
Start date
Feb 20, 2025
Primary completion
Feb 2029 (estimated)
Completion
Apr 30, 2029 (estimated)
Last update
Aug 31, 2026

Study contacts

Michael RERA, PhD
Contact
michael.rera@cnrs.fr
+33781945974
Rachel HAUS, PhD
Contact
evdg-dpar.contact.fct@intradef.gouv.fr
Clément DUBOST, MD, PhD
principal investigator · National teaching army hospital BEGIN (Hôpital National d'Instruction des Armées BEGIN)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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