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Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

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ClinicalTrials.gov Identifier: NCT00199641
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 4, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
-Mechanically Ventilated Patients Device: enteral nutrition

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : July 2002
Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

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 Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 4, 2008
Last Verified: December 2008