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

Not Applicable

Terminated

• Conditions: Shock; Acute Respiratory Failure
• Interventions: Other: Enteral Nutrition; Other: Parenteral nutrition

• Registration Number: NCT03852940
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Study Timeline

• Study Start: 2015-01-27
• Primary Completion: 2015-07-07
• Status Verified: 2017-07
• Study Completion: 2017-07
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2019-02-22
• Last Update Submitted: 2019-02-22
• Study First Posted: 2019-02-25
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 169

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enteral nutrition	Enteral Nutrition	Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
Parenteral nutrition	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.

Primary Outcome Measures

Name	Time	Method
Plasma citrulline level	72 hours

Secondary Outcome Measures

Name	Time	Method
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 citrulline is ≤10 μL/L	Day 0, Day 3, Day 8
mean plasma I-FABP	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 whose plasma I-FABP is ≥100 pg/mL	Day 0, Day 3, Day 8
mean plasma citrulline	Day 0, Day 3, Day 8
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)

Trial Locations

Locations (6)

CH de Dieppe; 🇫🇷 Dieppe, France

CHU Saint Louis; 🇫🇷 Paris, France

CHU Tours; 🇫🇷 Tours, France

CHU Amiens; 🇫🇷 Amiens, France

CHU Lille; 🇫🇷 Lille, France

Centre hospitalier d'Annecy; 🇫🇷 Annecy, France