Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00199641
First received: September 14, 2005
Last updated: December 2, 2008
Last verified: December 2008
  Purpose

The aim of this study is to compare two strategies of early enteral nutrition in terms of efficacy and complications in mechanically ventilated patients.


Condition Intervention
-Mechanically Ventilated Patients
Device: enteral nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Incidence of nutrition failure (diarrhea, ileus, vomiting, aspiration pneumonia, elevated residual gastric volume)

Secondary Outcome Measures:
  • -Measured nutrition amount when compared to theorical nutrition during ICU stay
  • -Measured nutrition amount when compared to theorical nutrition during the first three days
  • -Influence of prokinetic drugs on nutrition quality

Enrollment: 100
Study Start Date: July 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (> 18 ans)
  • Mechanical ventilation for > 72 hours
  • Planned enteral nutrition
  • Informed consent

Exclusion Criteria:

  • Body Mass Index < 20 kg/m2
  • Enteral nutrition non indicated (ileus, splanchnic ischemia..)
  • Shock (use of catecholamines, arterial blood pressure < 90 mmHg, peripheral hypoperfusion, elevation of lactates > x 1,5 normal value)
  • Contraindications for gastric tube
  • Pregnancy
  • Previous enrollment in the present study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199641

Locations
France
Service de Réanimation
Angouleme, France
Service de réanimation Polyvalente
Limoges, France
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Bruno François, MD University Hospital, Limoges
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00199641     History of Changes
Other Study ID Numbers: DGS 2002/0361
Study First Received: September 14, 2005
Last Updated: December 2, 2008
Health Authority: France: Ministry of Health

ClinicalTrials.gov processed this record on April 22, 2014