Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients
Sponsor
University Hospital, Limoges (Other)
Overall Status
Completed
CT.gov ID
NCT00199641
Collaborator
(none)
100
2
50
Study Details
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 | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
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
:
Jul 1, 2002
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de Réanimation | Angouleme | France | ||
| 2 | Service de réanimation Polyvalente | Limoges | France |
Sponsors and Collaborators
- University Hospital, Limoges
Investigators
- Principal Investigator: Bruno François, MD, University Hospital, Limoges
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00199641
Other Study ID Numbers:
- DGS 2002/0361
First Posted:
Sep 20, 2005
Last Update Posted:
Dec 4, 2008
Last Verified:
Dec 1, 2008