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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00199641 |
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Date of registration:
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14/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients
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Scientific title:
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Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients |
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Date of first enrolment:
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July 2002 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00199641 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Bruno François, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Limoges |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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-Mechanically Ventilated Patients
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Intervention(s)
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Device: enteral nutrition
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Primary Outcome(s)
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Incidence of nutrition failure (diarrhea, ileus, vomiting, aspiration pneumonia, elevated residual gastric volume)
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Secondary Outcome(s)
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-Measured nutrition amount when compared to theorical nutrition during ICU stay
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-Influence of prokinetic drugs on nutrition quality
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-Measured nutrition amount when compared to theorical nutrition during the first three days
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Secondary ID(s)
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DGS 2002/0361
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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