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Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199641
First Posted: September 20, 2005
Last Update Posted: December 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Limoges
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00199641     History of Changes
Other Study ID Numbers: DGS 2002/0361
First Submitted: September 14, 2005
First Posted: September 20, 2005
Last Update Posted: December 4, 2008
Last Verified: December 2008


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