N/A
N=2,410
Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines
Acute Respiratory Failure · Shock
Bottom Line
View on ClinicalTrials.gov: NCT01802099 ↗Enrolled (actual)
2,410
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Mortality — 422; 443 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enteral nutrition (Other); Parenteral nutrition (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre Hospitalier Departemental Vendee
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
422; 443 | — |
| SECONDARY Mortality Rate |
507; 530 | — |
| SECONDARY Ventilator-associated Pneumonia Rate |
— | — |
| SECONDARY Nosocomial Infections Rate |
— | — |
| SECONDARY Length of Stay in Intensive Care Unit (ICU) |
— | — |
| SECONDARY Length of Stay in Hospital |
— | — |
| SECONDARY Variations in Sepsis-related Organ Failure Assessment (SOFA) Score |
— | — |
| SECONDARY Calories Intake |
— | — |
| SECONDARY Proportion of Patients Given 100% of the Calorie Target |
— | — |
| SECONDARY Cumulative Calorie Deficit From Day 0 to Day 7 |
— | — |
| SECONDARY Hospital Mortality Rate |
— | — |
| SECONDARY Intensive Care Unit (ICU) Mortality Rate |
— | — |
| SECONDARY Acute Bowel Ischemia Rate |
— | — |
| SECONDARY Vomiting Rate |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01802099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.