NCT00199641

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

December 4, 2008

Status Verified

December 1, 2008

First QC Date

September 14, 2005

Last Update Submit

December 2, 2008

Conditions

-Mechanically Ventilated Patients

Outcome Measures

Primary Outcomes (1)

  • Incidence of nutrition failure (diarrhea, ileus, vomiting, aspiration pneumonia, elevated residual gastric volume)

Secondary Outcomes (3)

  • -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

Interventions

enteral nutritionDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (\> 18 ans)
  • Mechanical ventilation for \> 72 hours
  • Planned enteral nutrition
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de Réanimation

Angoulême, France

Location

Service de réanimation Polyvalente

Limoges, France

Location

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Bruno François, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 20, 2005

Study Start

July 1, 2002

Last Updated

December 4, 2008

Record last verified: 2008-12

Locations

FR(2)