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

Primary Purpose

Acute Respiratory Failure, Shock

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Parenteral nutrition
Enteral Nutrition
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Respiratory Failure focused on measuring vasoactive drug, mechanical ventilation, early enteral nutrition, intensive care unit, early parenteral nutrition, critical care medicine, nosocomial infection, mortality, shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens
  • Centre hospitalier d'Annecy
  • CH de Dieppe
  • CHU Lille
  • CHU Saint Louis
  • CHU Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Parenteral nutrition

Enteral nutrition

Arm Description

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.

Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.

Outcomes

Primary Outcome Measures

Plasma citrulline level

Secondary Outcome Measures

SOFA score
plasma levels of citrulline
I-FABP
proportion of patients whose plasma I-FABP is ≥100 pg/mL
proportion of patients whose plasma citrulline is ≤10 μL/L
mean plasma I-FABP
mean plasma citrulline
proportion of patients with at least one episode of bacteremia
proportion of patients with at least one episode of gastrointestinal intolerance
proportion of patients with at least one episode of diarrhea

Full Information

First Posted
July 18, 2017
Last Updated
February 22, 2019
Sponsor
Centre Hospitalier Departemental Vendee
Collaborators
Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT03852940
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Data Safety and Monitoring Board 's request
Study Start Date
January 27, 2015 (Actual)
Primary Completion Date
July 7, 2015 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
Collaborators
Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parenteral nutrition
Arm Type
Other
Arm Description
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.
Arm Title
Enteral nutrition
Arm Type
Other
Arm Description
Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
Intervention Type
Other
Intervention Name(s)
Parenteral nutrition
Other Intervention Name(s)
Intravenous nutrition, intravenous feeding
Intervention Type
Other
Intervention Name(s)
Enteral Nutrition
Other Intervention Name(s)
Enteral feeding
Primary Outcome Measure Information:
Title
Plasma citrulline level
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
SOFA score
Time Frame
first week
Title
plasma levels of citrulline
Time Frame
Day 0, Day 3, Day 8
Title
I-FABP
Time Frame
Day 0, Day 3, Day 8
Title
proportion of patients whose plasma I-FABP is ≥100 pg/mL
Time Frame
Day 0, Day 3, Day 8
Title
proportion of patients whose plasma citrulline is ≤10 μL/L
Time Frame
Day 0, Day 3, Day 8
Title
mean plasma I-FABP
Time Frame
Day 0, Day 3, Day 8
Title
mean plasma citrulline
Time Frame
Day 0, Day 3, Day 8
Title
proportion of patients with at least one episode of bacteremia
Time Frame
until discharge from ICU (average: 10 days)
Title
proportion of patients with at least one episode of gastrointestinal intolerance
Time Frame
until discharge from ICU (average: 10 days)
Title
proportion of patients with at least one episode of diarrhea
Time Frame
until discharge from ICU (average: 10 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean REIGNIER, MD, PhD
Organizational Affiliation
CHD Vendee
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre hospitalier d'Annecy
City
Annecy
ZIP/Postal Code
74374
Country
France
Facility Name
CH de Dieppe
City
Dieppe
ZIP/Postal Code
76202
Country
France
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHU Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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