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Completed

NCT Number: NCT01802099

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

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.

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Key information

Conditions

Acute Respiratory Failure Cross Infection Disease Attributes Hyperphagia Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral nutrition

Other

Other names: Enteral feeding

Parenteral nutrition

Other

Other names: Intravenous nutrition, intravenous feeding

Primary outcomes

  1. Mortality

    Time frame: 28 days

Secondary outcomes

  1. Mortality Rate

    Time frame: 90 days

  2. Ventilator-associated Pneumonia Rate

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

  3. Nosocomial Infections Rate

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

    Bloodstream infection Urinary tract infection Catheter-related infection Other infections

  4. Length of Stay in Intensive Care Unit (ICU)

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

  5. Length of Stay in Hospital

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

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

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

  7. Calories Intake

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

  8. Proportion of Patients Given 100% of the Calorie Target

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

  9. Cumulative Calorie Deficit From Day 0 to Day 7

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

  10. Hospital Mortality Rate

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

  11. Intensive Care Unit (ICU) Mortality Rate

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

  12. Acute Bowel Ischemia Rate

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

  13. Vomiting Rate

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Collaborators

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

Registry information

Official study title

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

Acronym: NUTRIREA2

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 1, 2013
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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