Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines (NUTRIREA2)

February 22, 2019 updated by: Centre Hospitalier Departemental Vendee

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2411

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Angers, France, 49933
        • CHU d'Angers
      • Annecy, France, 74374
        • Centre Hospitalier D'annecy
      • Beauvais, France, 60021
        • Centre Hospitalier De Beauvais
      • Besançon, France, 25000
        • CHU Besançon-Hôpital Jean Minjoz
      • Bordeaux, France, 33076
        • CHU Pellegrin Tripode
      • Chartres, France, 28018
        • CH Louis Pasteur
      • Clermont Ferrand, France, 63003
        • CHU Gabriel Montpied, Clermont Ferrand
      • Colombes, France, 92701
        • CHU Louis Mourier
      • Dieppe, France, 76202
        • CH de Dieppe
      • Dijon, France, 21079
        • CHU Dijon
      • Garches, France, 92380
        • Hôpital Raymond Poincarre
      • Grenoble, France, 38043
        • CHU Grenoble
      • La Roche sur Yon, France, 85000
        • CHD Vendée - service de réanimation
      • Le Kremlin-Bicêtre, France, 94275
        • CHU de Bicêtre
      • Lens, France, 62307
        • CH Docteur Schaffner
      • Lille, France, 59000
        • CHU Lille
      • Lyon, France, 69437
        • Hospices Civils de Lyon
      • Lyon, France, 69004
        • CHU de Lyon- Hôpital de la Croix Rousse
      • Melun, France, 77000
        • CH Marc Jacquet
      • Montauban, France, 82013
        • CH de Montauban
      • Montreuil, France, 93105
        • CHI André Grégoire
      • Mulhouse, France, 68100
        • Hôpital Emile Muller
      • Nantes, France, 44093
        • CHU de Nantes - Hotel Dieu
      • Nantes, France, 44000
        • CHU de Nantes, Hôpital Laennec
      • Orléans, France, 45067
        • Hôpital de La Source, CHR Orléans
      • Paris, France, 75014
        • Groupe hospitalier Paris saint Joseph
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75014
        • CHU Paris Cochin
      • Paris, France, 75012
        • CHU Saint-Antoine
      • Paris, France, 75010
        • CHU Saint Louis
      • Pointe À Pitre, France, 97159
        • CHU Pointe à Pitre - Abymes
      • Poitiers, France, 86021
        • CHU Poitiers
      • Rodez, France, 12000
        • Centre Hospitalier Jacques Puel
      • Saint Denis, France, 93200
        • Hôpital Delafontaine
      • Saint Etienne, France, 42055
        • CHU Saint Etienne-Hôpital Nord
      • Saint Malo, France, 35400
        • CH de Saint Malo
      • Strasbourg, France, 67091
        • CHU de Strasbourg - Nouvel Hopital Civil
      • Strasbourg, France, 67098
        • CHU de Strasbourg - Hôpital de Hautepierre
      • Suresnes, France, 92150
        • Hopital Foch
      • Tours, France, 37044
        • Chu Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: Parenteral nutrition
Other Names:
  • Intravenous nutrition
  • intravenous feeding
Other: Enteral nutrition
Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
Other: Enteral nutrition
Other Names:
  • Enteral feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 90 days
90 days
Ventilator-associated pneumonia rate
Time Frame: until weaning of mechanical ventilation (average: 7 days)
until weaning of mechanical ventilation (average: 7 days)
Nosocomial infections rate
Time Frame: until discharge from ICU (average: 10 days)
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)
Time Frame: until discharge from ICU (average: 10 days)
until discharge from ICU (average: 10 days)
Length of stay in hospital
Time Frame: until discharge from hospital (average: 17 days)
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
first week (7 days) of mechanical ventilation
calories intake
Time Frame: until weaning of mechanical ventilation (average : 7 days)
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)
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
During the first week (7 days) of mechanical ventilation
Hospital mortality rate
Time Frame: Until discharge from hospital (average : 17 days)
Until discharge from hospital (average : 17 days)
Intensive Care Unit (ICU) mortality rate
Time Frame: until discharge from ICU (average: 10 days)
until discharge from ICU (average: 10 days)
Acute bowel ischemia rate
Time Frame: until weaning of mechanical ventilation (average: 7 days)
until weaning of mechanical ventilation (average: 7 days)
Vomiting rate
Time Frame: until weaning of mechanical ventilation (average: 7 days)
until weaning of mechanical ventilation (average: 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Ministry of Health, France
University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 27, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD085-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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