Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines

Study Overview
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Brief Summary
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The purpose of this study is to assess the hypothesis that, as compared to early intravenous feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in critically ill patients treated with mechanical ventilation and vasoactive drug.

Official Title
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Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines: Multicenter, Randomized Controlled Trial (NUTRIREA-2)

Conditions
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Acute Respiratory Failure, Shock

Intervention / Treatment
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* Other: Enteral nutrition
* Other: Parenteral 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 |
| --- | --- | --- |
| Mortality |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate |  | 90 days | 
| Ventilator-associated pneumonia rate |  | until weaning of mechanical ventilation (average: 7 days) | 
| Nosocomial infections rate | Bloodstream infection Urinary tract infection Catheter-related infection Other infections | until discharge from ICU (average: 10 days) | 
| Length of stay in Intensive Care Unit (ICU) |  | until discharge from ICU (average: 10 days) | 
| Length of stay in hospital |  | until discharge from hospital (average: 17 days) | 
| Variations in Sepsis-related Organ Failure Assessment (SOFA) score |  | first week (7 days) of mechanical ventilation | 
| calories intake |  | until weaning of mechanical ventilation (average : 7 days) | 
| Proportion of patients given 100% of the calorie target |  | until weaning of mechanical ventilation (average: 7 days) | 
| cumulative calorie deficit from day 0 to day 7 |  | During the first week (7 days) of mechanical ventilation | 
| Hospital mortality rate |  | Until discharge from hospital (average : 17 days) | 
| Intensive Care Unit (ICU) mortality rate |  | until discharge from ICU (average: 10 days) | 
| Acute bowel ischemia rate |  | until weaning of mechanical ventilation (average: 7 days) | 
| Vomiting rate |  | until weaning of mechanical ventilation (average: 7 days) | 

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