Multivisceral Failure SyndromeBLUE-REANCT06845865
Measurement of Intestinal Permeability in Intensive Care Patients With Single or Multiple Organ Failure
An observational study of Multivisceral Failure Syndrome and Monovisceral Failure, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multivisceral Failure Syndrome, Monovisceral Failure, Infection in ICU
- What is being tested?
- enteric dyed solution
- Type of treatment
- Pill or oral medicine
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2025to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hosptalized adults in ICU, France.
Who may be able to join
- 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:
Show all 11Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rachel HAUS, PhD contact
France1 site, 1 recruiting
- Recruiting
Hopital Bégin
Vincennes
Clément Dubost, MD, PhD, +331 43 98 50 48, clement.dubost@ens-paris-saclay.fr
About this study
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.
- Being tested
- enteric dyed solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteric dyed solutionDietary supplement
Oral administration of 0.5 mg/kg of body weight of food coloring dye
| Study group | Role | What they receive |
|---|---|---|
| patients with mono-organ failure | 20 < SAPS2 < 40 Receives: Dietary Supplement: enteric dyed solution | |
| patients with multi-visceral failure | 60 < SAPS2 < 80 Receives: Dietary Supplement: enteric dyed solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 2024-2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start20 Feb 2025
- Primary completionFeb 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multivisceral Failure SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Borelli UMR 9010
- Responsible party
- Sponsor
- Investigators
- Clément DUBOST, MD, PhD, Principal investigator, National teaching army hospital BEGIN (Hôpital National d'Instruction des Armées BEGIN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845865
- Sponsor's protocol ID
- 2021PPRC02
- Other IDs
- 2023-A02005-40
- Acronym
- BLUE-REA
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30502249Dambroise 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 27002861Doig 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 9700119Gayat 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 29347987Harris 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Intestinal Permeability in Intensive Care Patients With Single or Multiple Organ Failure
- ClinicalTrials.gov ID
- NCT06845865
- Acronym / sponsor ID
- BLUE-REA / 2021PPRC02
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Collaborators
- Centre Borelli UMR 9010
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with mono-organ failure | – | Dietary Supplement: enteric dyed solution20 < SAPS2 < 40 |
| patients with multi-visceral failure | – | Dietary Supplement: enteric dyed solution60 < SAPS2 < 80 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hosptalized adults in ICU, France.
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteric dyed solutionOral administration of 0.5 mg/kg of body weight of food coloring dye | Dietary supplement | patients with mono-organ failure, patients with multi-visceral failure |
Primary outcome
intestinal failure and survival 90 days post inclusion
Time frame: 2024-2027
Evaluation of the impact of changes in permeability (classified into 3 categories: absent, moderately increased, and highly increased) on patient survival at day 90
1 secondary outcome
intestinal permeability as a function of organ failure
Time frame: 2024-2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 30502249Angarita 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.
- Background: PubMed 27002861Dambroise 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.
- Background: PubMed 9700119Doig 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.
- Background: PubMed 29347987Gayat 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.
- Background: PubMed 1578045Harris 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel HAUS, PhD contact
Clément DUBOST, MD, PhD principal investigator
National teaching army hospital BEGIN (Hôpital National d'Instruction des Armées BEGIN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multivisceral Failure Syndrome and Monovisceral Failure, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael RERA, PhD (+33781945974, michael.rera@cnrs.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intestinal failure and survival 90 days post inclusion (time frame: 2024-2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06845865, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.