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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02005-40 | Other Identifier | Comité de protection des personnes Ouest IV |
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| Name | Class |
|---|---|
| Centre Borelli UMR 9010 | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with mono-organ failure | 20 < SAPS2 < 40 |
| |
| patients with multi-visceral failure | 60 < SAPS2 < 80 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteric dyed solution | Dietary Supplement | Oral administration of 0.5 mg/kg of body weight of food coloring dye |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2024-2027 |
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Inclusion Criteria:
Patient with single organ failure, secondary to sepsis, hospitalized in intensive care for a foreseeable duration of > 48 hours
Second group of patients with multi-organ failure:
Exclusion Criteria:
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hosptalized adults in ICU, France.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael RERA, PhD | Contact | +33781945974 | michael.rera@cnrs.fr | |
| Rachel HAUS, PhD | Contact | evdg-dpar.contact.fct@intradef.gouv.fr |
| Name | Affiliation | Role |
|---|---|---|
| Clément DUBOST, MD, PhD | National teaching army hospital BEGIN (Hôpital National d'Instruction des Armées BEGIN) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Bégin | Recruiting | Vincennes | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30502249 | Background | 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. | |
| 27002861 | 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. |
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| 9700119 | 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. |
| 29347987 | 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. |
| 1578045 | 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. |