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

Acute Respiratory Failure Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03852940
• Other study ID #: CHD085-12
• Status: Terminated
• Phase: N/A
• Start date: January 27, 2015
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 169
• Est. completion date: July 2017
• Est. primary completion date: July 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Shock

Intervention

Other:
• Parenteral nutrition

• Enteral Nutrition

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	Centre hospitalier d'Annecy	Annecy
France	CH de Dieppe	Dieppe
France	CHU Lille	Lille
France	CHU Saint Louis	Paris
France	CHU Tours	Tours

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee	Institut National de la Santé Et de la Recherche Médicale, France, Ministry of Health, France, University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma citrulline level		72 hours
Secondary	SOFA score		first week
Secondary	plasma levels of citrulline		Day 0, Day 3, Day 8
Secondary	I-FABP		Day 0, Day 3, Day 8
Secondary	proportion of patients whose plasma I-FABP is =100 pg/mL		Day 0, Day 3, Day 8
Secondary	proportion of patients whose plasma citrulline is =10 µL/L		Day 0, Day 3, Day 8
Secondary	mean plasma I-FABP		Day 0, Day 3, Day 8
Secondary	mean plasma citrulline		Day 0, Day 3, Day 8
Secondary	proportion of patients with at least one episode of bacteremia		until discharge from ICU (average: 10 days)
Secondary	proportion of patients with at least one episode of gastrointestinal intolerance		until discharge from ICU (average: 10 days)
Secondary	proportion of patients with at least one episode of diarrhea		until discharge from ICU (average: 10 days)