Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

This study has been completed.

Sponsored by:	University Hospital, Limoges
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00199641

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Polyvalente
Limoges, France
Service de Réanimation
Angouleme, France

Sponsors and Collaborators

University Hospital, Limoges

Investigators

Principal Investigator:

Bruno François, MD

University Hospital, Limoges

More Information

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

ClinicalTrials.gov processed this record on January 15, 2009