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

Not Applicable

Terminated

• Conditions: Shock; Acute Respiratory Failure

• Registration Number: NCT01802099
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-02-28
• Study Start: 2013-03
• Study First Posted: 2013-03-01
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2411

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mortality	28 days

Secondary Outcome Measures

Name	Time	Method
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)
Mortality rate	90 days
Ventilator-associated pneumonia rate	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
Nosocomial infections rate	until discharge from ICU (average: 10 days)	Bloodstream infection Urinary tract infection Catheter-related infection Other infections
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)
Length of stay in Intensive Care Unit (ICU)	until discharge from ICU (average: 10 days)
Vomiting rate	until weaning of mechanical ventilation (average: 7 days)

Trial Locations

Locations (41)

CHU Amiens; 🇫🇷 Amiens, France

CHU d'Angers; 🇫🇷 Angers, France

Centre hospitalier d'Annecy; 🇫🇷 Annecy, France

Centre Hospitalier de Beauvais; 🇫🇷 Beauvais, France

CHU Besançon-Hôpital Jean Minjoz; 🇫🇷 Besançon, France

CHU Pellegrin Tripode; 🇫🇷 Bordeaux, France

CH Louis Pasteur; 🇫🇷 Chartres, France

CHU Gabriel Montpied, Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

CHU Louis Mourier; 🇫🇷 Colombes, France

CH de Dieppe; 🇫🇷 Dieppe, France

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