Clinical trial NCT03852940: Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamine
Official title: Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Respiratory Failure
Shock
Keywords: vasoactive drug
mechanical ventilation
early enteral nutrition
intensive care unit
early parenteral nutrition
critical care medicine
nosocomial infection
mortality
shock
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Institut National de la Santé Et de la Recherche Médicale, France
name: University Hospital, Tours
First posted: 2019-02-25
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: Published data suggest that enteral nutrition may be associated with improved preservation of the gut lymphoid tissues and gut immune function, as well as with decreased gut mucosa permeability, thereby diminishing the risk of organ failure. Citrulline is an amino acid produced from glutamine by small-bowel enterocytes. Plasma citrulline levels reflect functional enterocyte mass. Intestinal fatty acid-binding protein (I-FABP, also known as FABP2) is a small protein found in the cytosol of small-bowel enterocytes. Plasma I-FABP is normally undetectable and, when elevated, constitutes a reliable marker for enterocyte damage. The hypothesis underlying this ancillary study is that first-line enteral nutrition is associated with improved gut mucosa integrity and function compared to parenteral nutrition.

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

Primary outcomes:
measure: Plasma citrulline level
timeFrame: 72 hours
Secondary outcomes:
measure: SOFA score
timeFrame: first week
measure: plasma levels of citrulline
timeFrame: Day 0, Day 3, Day 8
measure: I-FABP
timeFrame: Day 0, Day 3, Day 8
measure: proportion of patients whose plasma I-FABP is ≥100 pg/mL
timeFrame: Day 0, Day 3, Day 8
measure: proportion of patients whose plasma citrulline is ≤10 μL/L
timeFrame: Day 0, Day 3, Day 8
measure: mean plasma I-FABP
timeFrame: Day 0, Day 3, Day 8
measure: mean plasma citrulline
timeFrame: Day 0, Day 3, Day 8
measure: proportion of patients with at least one episode of bacteremia
timeFrame: until discharge from ICU (average: 10 days)
measure: proportion of patients with at least one episode of gastrointestinal intolerance
timeFrame: until discharge from ICU (average: 10 days)
measure: proportion of patients with at least one episode of diarrhea
timeFrame: until discharge from ICU (average: 10 days)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Annecy
country: France
facility: Centre hospitalier d'Annecy
city: Dieppe
country: France
facility: CH de Dieppe
city: Lille
country: France
facility: CHU Lille
city: Paris
country: France
facility: CHU Saint Louis
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHD Vendee
name: Jean REIGNIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: