Study Stopped
Data Safety and Monitoring Board 's request
Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamine
1 other identifier
interventional
169
1 country
6
Brief Summary
To demonstrate that a strategy involving early first-line enteral nutrition is associated with improved preservation of gut mucosa integrity, as assessed based on the plasma citrulline level at H72, compared to a strategy involving early first-line parenteral nutrition
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
February 25, 2019
CompletedFebruary 25, 2019
July 1, 2017
5 months
July 18, 2017
February 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma citrulline level
72 hours
Secondary Outcomes (10)
SOFA score
first week
plasma levels of citrulline
Day 0, Day 3, Day 8
I-FABP
Day 0, Day 3, Day 8
proportion of patients whose plasma I-FABP is ≥100 pg/mL
Day 0, Day 3, Day 8
proportion of patients whose plasma citrulline is ≤10 μL/L
Day 0, Day 3, Day 8
- +5 more secondary outcomes
Study Arms (2)
Parenteral nutrition
OTHERPatients 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.
Enteral nutrition
OTHERPatients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Departemental Vendeelead
- Ministry of Health, Francecollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- University Hospital, Tourscollaborator
Study Sites (6)
CHU Amiens
Amiens, 80054, France
Centre hospitalier d'Annecy
Annecy, 74374, France
CH de Dieppe
Dieppe, 76202, France
CHU Lille
Lille, 59000, France
CHU Saint Louis
Paris, 75010, France
CHU Tours
Tours, 37044, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean REIGNIER, MD, PhD
CHD Vendee
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2017
First Posted
February 25, 2019
Study Start
January 27, 2015
Primary Completion
July 7, 2015
Study Completion
July 1, 2017
Last Updated
February 25, 2019
Record last verified: 2017-07