Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamine

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)

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

Study Overview

• Status: Terminated
• Conditions: Shock; Acute Respiratory Failure
• Intervention / Treatment: Other: Parenteral nutrition; Other: Enteral 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.

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens
  • Annecy, France, 74374
    • Centre Hospitalier d'Annecy
  • Dieppe, France, 76202
    • CH de Dieppe
  • Lille, France, 59000
    • CHU Lille
  • Paris, France, 75010
    • CHU Saint Louis
  • Tours, France, 37044
    • Chu Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Parenteral nutrition; Patients 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.	Other: Parenteral nutrition; Other Names: Intravenous nutrition; intravenous feeding
OTHER: Enteral nutrition; Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.	Other: Enteral Nutrition; Other Names: Enteral feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma citrulline level	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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
mean plasma I-FABP	Day 0, Day 3, Day 8
mean plasma citrulline	Day 0, Day 3, Day 8
proportion of patients with at least one episode of bacteremia	until discharge from ICU (average: 10 days)
proportion of patients with at least one episode of gastrointestinal intolerance	until discharge from ICU (average: 10 days)
proportion of patients with at least one episode of diarrhea	until discharge from ICU (average: 10 days)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Ministry of Health, France; University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 27, 2015
• Primary Completion (ACTUAL): July 7, 2015
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (ACTUAL): February 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: intensive care unit; mechanical ventilation; shock; mortality; early parenteral nutrition; nosocomial infection; critical care medicine; vasoactive drug; early enteral nutrition
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: CHD085-12