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

N/ATerminatedNCT01802099

Centre Hospitalier Departemental Vendee2,411 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

2,411

Conditions

Acute Respiratory Failure Shock

Interventions

Enteral nutritionOTHER

Parenteral nutritionOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (41)

Outcomes

Primary Outcomes

Mortality

Time frame: 28 days

Secondary Outcomes

Mortality Rate

Time frame: 90 days

Ventilator-associated Pneumonia Rate

Time frame: until weaning of mechanical ventilation (average: 7 days)

Nosocomial Infections Rate

Bloodstream infection Urinary tract infection Catheter-related infection Other infections

Time frame: until discharge from ICU (average: 10 days)

Length of Stay in Intensive Care Unit (ICU)

Time frame: until discharge from ICU (average: 10 days)

Length of Stay in Hospital

Time frame: until discharge from hospital (average: 17 days)

Variations in Sepsis-related Organ Failure Assessment (SOFA) Score

Time frame: first week (7 days) of mechanical ventilation

Calories Intake

Time frame: until weaning of mechanical ventilation (average : 7 days)

Proportion of Patients Given 100% of the Calorie Target

Time frame: until weaning of mechanical ventilation (average: 7 days)

Cumulative Calorie Deficit From Day 0 to Day 7

Time frame: During the first week (7 days) of mechanical ventilation

Hospital Mortality Rate

Data from ClinicalTrials.gov

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