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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014