Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamine

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)

Conditions
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Acute Respiratory Failure, Shock

Intervention / Treatment
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* Other: Parenteral nutrition
* Other: Enteral Nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasive mechanical ventilation expected to be required more than 48 hours Nutrition started within 24 hours after initiation of endotracheal mechanical ventilation Treatment with vasoactive drug administered via a central venous catheter Age over 18 years Signed information Exclusion Criteria: Abdominal surgery within 1 month before inclusion History of esophageal, gastric, duodenal or pancreatic surgery Bleeding from the esophagus, stomach or bowel enteral nutrition via gastrostomy or jejunostomy pregnancy Treatment-limitation decisions Current inclusion in a trial on comparison between enteral and parenteral nutrition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Parenteral nutrition<br>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. | Other: Parenteral nutrition<br> <br> * Other names: intravenous feeding;|
| Other: Enteral nutrition<br>Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. | Other: Enteral Nutrition<br> <br> * Other names: Enteral feeding;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma citrulline level |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOFA score |  | first week | 
| plasma levels of citrulline |  | Day 0, Day 3, Day 8 | 
| I-FABP |  | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vasoactive drug, mechanical ventilation, early enteral nutrition, intensive care unit, early parenteral nutrition, critical care medicine, nosocomial infection, mortality, shock