Acute Respiratory Failure, Shock
Conditions
Keywords
vasoactive drug, mechanical ventilation, early enteral nutrition, intensive care unit, early parenteral nutrition, critical care medicine, nosocomial infection, mortality, shock
Brief summary
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
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.
Interventions
OTHERParenteral nutrition
OTHEREnteral Nutrition
Sponsors
Ministry of Health, France
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Tours
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma citrulline level | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| SOFA score | first week |
| 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) |
| mean plasma I-FABP | Day 0, Day 3, Day 8 |
Countries
France
Outcome results
None listed