Completed

NUTRIREA2Early Enteral vs. Intravenous Nutrition Impact on Mortality in Critically Ill Patients

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Study Aim

This study aims to compare the impact of early enteral nutrition (feeding through a tube) versus intravenous nutrition on mortality in critically ill patients.

What is being tested

Nutrition Through Veins

+ Feeding through the digestive system

Other
Who is being recruted

Iatrogenic Disease+7

+ Infections

+ Pathologic Processes

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorCentre Hospitalier Departemental Vendee
Last updated: September 4, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

This study focuses on critically ill patients who need mechanical ventilation and vasoactive drugs. The main goal is to compare two methods of providing nutrition early on: through the vein (intravenous) and through the digestive system (enteral). The researchers believe that enteral nutrition might lead to a lower risk of death within 28 days, potentially improving the care for these patients. During the study, participants receive either intravenous or enteral nutrition. The primary outcome measured is mortality within 28 days. This helps determine which method of nutrition support is more effective for this specific patient population.

NCT01802099
Principal SponsorCentre Hospitalier Departemental Vendee
Last updated: September 4, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

2410 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Iatrogenic DiseaseInfectionsPathologic ProcessesSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsDisease AttributesCross InfectionHyperphagiaShock

Criteria

5 inclusion criteria required to participate
Age over 18 years
Invasive mechanical ventilation expected to be required more than 48 hours
Nutrition started within 24 hours after initiation of endotracheal mechanical ventilation
Signed information
Show More Criteria
7 exclusion criteria prevent from participating
Abdominal surgery within 1 month before inclusion
Bleeding from the esophagus, stomach or bowel
Current inclusion in a trial on comparison between enteral and parenteral nutrition
Enteral nutrition via gastrostomy or jejunostomy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Patients in this group will receive nutrition directly into their bloodstream during the first week of breathing support. After Day 3, if their condition improves, they may start receiving nutrition through a feeding tube. After Day 7, all will be fed through the feeding tube.

Group II

Participants in this group will be given nutrition directly into their digestive system through a tube, during the first week of mechanical ventilation treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 41 locations

CHU Amiens

Amiens, FranceOpen CHU Amiens in Google Maps

CHU d'Angers

Angers, France

Centre hospitalier d'Annecy

Annecy, France

Centre Hospitalier de Beauvais

Beauvais, France
Completed41 Study Centers