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Data Safety and Monitoring Board 's request
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| University Hospital, Tours | OTHER |
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To demonstrate that a strategy involving early first-line enteral nutrition is associated with improved preservation of gut mucosa integrity, as assessed based on the plasma citrulline level at H72, compared to a strategy involving early first-line parenteral nutrition
Published data suggest that enteral nutrition may be associated with improved preservation of the gut lymphoid tissues and gut immune function, as well as with decreased gut mucosa permeability, thereby diminishing the risk of organ failure. Citrulline is an amino acid produced from glutamine by small-bowel enterocytes. Plasma citrulline levels reflect functional enterocyte mass. Intestinal fatty acid-binding protein (I-FABP, also known as FABP2) is a small protein found in the cytosol of small-bowel enterocytes. Plasma I-FABP is normally undetectable and, when elevated, constitutes a reliable marker for enterocyte damage. The hypothesis underlying this ancillary study is that first-line enteral nutrition is associated with improved gut mucosa integrity and function compared to parenteral nutrition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parenteral nutrition | Other | Patients will receive parenteral nutrition during the first week of mechanical ventilation. After Day 3, the parenteral route may be switched to the enteral route if shock resolve (vasoactive drug stopped since 24 hours and serum lactate level < 2 mmol/l). After Day 7, all patients will be fed via the enteral route. |
|
| Enteral nutrition | Other | Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral nutrition | Other |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma citrulline level | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| SOFA score | first week | |
| plasma levels of citrulline | Day 0, Day 3, Day 8 | |
| I-FABP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean REIGNIER, MD, PhD | CHD Vendee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80054 | France | |||
| Centre hospitalier d'Annecy |
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| Enteral Nutrition |
| Other |
|
|
| Day 0, Day 3, Day 8 |
| proportion of patients whose plasma I-FABP is ≥100 pg/mL | Day 0, Day 3, Day 8 |
| proportion of patients whose plasma citrulline is ≤10 μL/L | Day 0, Day 3, Day 8 |
| mean plasma I-FABP | Day 0, Day 3, Day 8 |
| mean plasma citrulline | Day 0, Day 3, Day 8 |
| proportion of patients with at least one episode of bacteremia | until discharge from ICU (average: 10 days) |
| proportion of patients with at least one episode of gastrointestinal intolerance | until discharge from ICU (average: 10 days) |
| proportion of patients with at least one episode of diarrhea | until discharge from ICU (average: 10 days) |
| Annecy |
| 74374 |
| France |
| CH de Dieppe | Dieppe | 76202 | France |
| CHU Lille | Lille | 59000 | France |
| CHU Saint Louis | Paris | 75010 | France |
| CHU Tours | Tours | 37044 | France |
| ID | Term |
|---|---|
| D012769 | Shock |
| D006963 | Hyperphagia |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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