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Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines

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

Sites / Locations

  • CHU Amiens
  • Centre hospitalier d'Annecy
  • CHU Louis Mourier
  • CHU Lille
  • CHU Saint Louis
  • CHU Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

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

proportion of patients with abundant microaspiration (defined as a pepsin level >200 ng/mL in at least 30% of tracheal aspirates)
Every tracheal aspirate will be collected during 48hours following randomisation

Secondary Outcome Measures

Salivary amylase levels in tracheal aspirates.
Every tracheal aspirate will be collected during 48hours following randomisation. Salivary amylase will be analysed.

Full Information

First Posted
July 18, 2017
Last Updated
January 25, 2018
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
NCT03411447
Brief Title
Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines
Official Title
Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
stopped on 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 7, 2015 (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 evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions
Detailed Description
A common obstacle to enteral nutrition is gastrointestinal intolerance, with regurgitations potentially responsible for gastric-content aspiration. Several studies involving technetium 99m (99mTc) labeling of gastric contents have established that gastric-fluid microaspiration is common in critically ill patients receiving both endotracheal ventilation and enteral nutrition. However, to our knowledge, no studies have specifically addressed the role for enteral nutrition in the occurrence of microaspiration. The objective of this ancillary study is to compare the frequency of gastric-content microaspiration in patients given enteral versus parenteral nutrition during the NUTRIREA2 trial. The new knowledge of risk factors for microaspiration provided by this study may help to improve strategies for preventing microaspiration and ventilator-associated pneumonia (VAP).

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
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parenteral nutrition
Arm Type
Active Comparator
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
Active Comparator
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
proportion of patients with abundant microaspiration (defined as a pepsin level >200 ng/mL in at least 30% of tracheal aspirates)
Description
Every tracheal aspirate will be collected during 48hours following randomisation
Time Frame
48Hours following randomisation
Secondary Outcome Measure Information:
Title
Salivary amylase levels in tracheal aspirates.
Description
Every tracheal aspirate will be collected during 48hours following randomisation. Salivary amylase will be analysed.
Time Frame
48Hours following randomisation

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
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
CHU Louis Mourier
City
Colombes
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

Citations:
PubMed Identifier
30953553
Citation
Nseir S, Le Gouge A, Lascarrou JB, Lacherade JC, Jaillette E, Mira JP, Mercier E, Declercq PL, Sirodot M, Piton G, Tinturier F, Coupez E, Gaudry S, Djibre M, Thevenin D, Pasco J, Balduyck M, Zerimech F, Reignier J. Impact of nutrition route on microaspiration in critically ill patients with shock: a planned ancillary study of the NUTRIREA-2 trial. Crit Care. 2019 Apr 5;23(1):111. doi: 10.1186/s13054-019-2403-z.
Results Reference
derived

Learn more about this trial

Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines

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