Measurement of Intestinal Permeability in Intensive Care Patients With Single or Multiple Organ Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: enteric dyed solution.
- Who it may be relevant to
- Registry conditions: Multivisceral Failure Syndrome, Monovisceral Failure, Infection in ICU. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Dietary supplement enteric dyed solution
Oral administration of 0.5 mg/kg of body weight of food coloring dye
Primary outcome measures
- intestinal failure and survival 90 days post inclusion [Time frame: 2024-2027]
Secondary outcome measures (1)
- intestinal permeability as a function of organ failure [Time frame: 2024-2027]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hopital Bégin — Vincennes
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. PMID 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. PMID 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. PMID 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 surviv PMID 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. PMID 1578045
Identifiers
NCT: NCT06845865 · 2021PPRC02 · 2023-A02005-40