Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines

Study Overview
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Brief Summary
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To evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions

Detailed Description
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A common obstacle to enteral nutrition is gastrointestinal intolerance, with regurgitations potentially responsible for gastric-content aspiration. Several studies involving technetium 99m (99mTc) labeling of gastric contents have established that gastric-fluid microaspiration is common in critically ill patients receiving both endotracheal ventilation and enteral nutrition. However, to our knowledge, no studies have specifically addressed the role for enteral nutrition in the occurrence of microaspiration. The objective of this ancillary study is to compare the frequency of gastric-content microaspiration in patients given enteral versus parenteral nutrition during the NUTRIREA2 trial. The new knowledge of risk factors for microaspiration provided by this study may help to improve strategies for preventing microaspiration and ventilator-associated pneumonia (VAP).

Official Title
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Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration 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

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 |
| --- | --- |
| Active Comparator: 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;|
| Active Comparator: 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 |
| --- | --- | --- |
| proportion of patients with abundant microaspiration (defined as a pepsin level >200 ng/mL in at least 30% of tracheal aspirates) | Every tracheal aspirate will be collected during 48hours following randomisation | 48Hours following randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary amylase levels in tracheal aspirates. | Every tracheal aspirate will be collected during 48hours following randomisation. Salivary amylase will be analysed. | 48Hours following randomisation | 

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