Clinical Trials Directory

Trials / Terminated

TerminatedNCT03852940

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)

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
169 (actual)
Sponsor
Centre Hospitalier Departemental Vendee · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERParenteral nutrition
OTHEREnteral Nutrition

Timeline

Start date
2015-01-27
Primary completion
2015-07-07
Completion
2017-07-01
First posted
2019-02-25
Last updated
2019-02-25

Locations

6 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03852940. Inclusion in this directory is not an endorsement.