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NCT00199641 Clinical Trial

Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

Mechanically Ventilated Patients Clinical Trial

Official title:
Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00199641
Other study ID # DGS 2002/0361
Secondary ID
Status Completed
Phase N/A
First received September 14, 2005
Last updated December 2, 2008
Start date July 2002

Study information
Verified date December 2008
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• enteral nutrition

Locations
Country Name City State
France Service de Réanimation Angouleme
France Service de réanimation Polyvalente Limoges

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of nutrition failure (diarrhea, ileus, vomiting, aspiration pneumonia, elevated residual gastric volume)
Secondary -Measured nutrition amount when compared to theorical nutrition during ICU stay
Secondary -Measured nutrition amount when compared to theorical nutrition during the first three days
Secondary -Influence of prokinetic drugs on nutrition quality
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