NCT01802099
Completed
Not Applicable
Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines: Multicenter, Randomized Controlled Trial (NUTRIREA-2)
Overview
- Phase
- Not Applicable
- Intervention
- Parenteral nutrition
- Conditions
- Acute Respiratory Failure
- Sponsor
- Centre Hospitalier Departemental Vendee
- Enrollment
- 2410
- Locations
- 80
- Primary Endpoint
- Mortality
- Status
- Completed
- Last Updated
- 16 days ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Parenteral nutrition
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.
Intervention: Parenteral nutrition
Enteral nutrition
Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
Intervention: Enteral nutrition
Outcomes
Primary Outcomes
Mortality
Time Frame: 28 days
Secondary Outcomes
- Mortality rate(90 days)
- Ventilator-associated pneumonia rate(until weaning of mechanical ventilation (average: 7 days))
- Nosocomial infections rate(until discharge from ICU (average: 10 days))
- Length of stay in Intensive Care Unit (ICU)(until discharge from ICU (average: 10 days))
- Variations in Sepsis-related Organ Failure Assessment (SOFA) score(first week (7 days) of mechanical ventilation)
- Length of stay in hospital(until discharge from hospital (average: 17 days))
- 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))
- Mortality Rate(90 days)
- Ventilator-associated Pneumonia Rate(until weaning of mechanical ventilation (average: 7 days))
- Hospital Mortality Rate(Until discharge from hospital (average : 17 days))
- Nosocomial Infections Rate(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)
- 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))
Study Sites (80)
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