N/A
Completed N=2,410
Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines
Source: ClinicalTrials.gov NCT01802099 ↗Enrolled (actual)
2,410
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Mortality — 422; 443 Participants
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.
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 |
— | — |
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. Informational only — not medical advice.