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

August 13, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Andre Gregoire
      • Mulhouse, France, 68100
        • Hopital Emile Muller
      • Nantes, France, 44093
        • CHU de Nantes - Hôtel Dieu
      • Nantes, France, 44000
        • CHU de Nantes, Hopital Laennec
      • Orléans, France, 45067
        • Hôpital de La Source, CHR Orléans
      • Paris, France, 75014
        • Groupe hospitalier Paris saint Joseph
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France, 75014
        • CHU Paris Cochin
      • Paris, France, 75012
        • CHU Saint-Antoine
      • Paris, France, 75010
        • CHU Saint Louis
      • Point À Pitre, France, 97110
        • 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
      • St-Malo, France, 35400
        • CH de Saint Malo
      • Strasbourg, France, 67091
        • CHU de Strasbourg - Nouvel Hôpital Civil
      • Strasbourg, France, 67098
        • CHU de Strasbourg - Hôpital de Hautepierre
      • Suresnes, France, 92150
        • Hôpital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mortality
Time Frame: 28 days
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Departemental Vendee

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France
Ministry of Health, France
University Hospital, Tours

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean Reignier, MD, PhD, CHD Vendée

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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