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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00916591
Other study ID # UZBrussels
Secondary ID 2009-012342-23
Status Not yet recruiting
Phase N/A
First received June 5, 2009
Last updated June 5, 2009
Start date September 2009

Study information

Verified date June 2009
Source Universitair Ziekenhuis Brussel
Contact Nele Van De Winkel
Phone 00324773348
Email nelevandewinkel@hotmail.com
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Observational

Clinical Trial Summary

The purpose of this study is to compare the effect of two drugs that can help in the prevention of regurgitation during the administration of enteral nutrition and define which one is the most effective.


Description:

Two prokinetic drugs (metoclopramide and erythromycin) will be compared during the administration of enteral nutrition in critically ill patients. We would like to know which one is the most effective in preventing regurgitation and risk of aspiration, which is a common complication of enteral nutritional support. This will be evaluated by measuring gastric residue every six hours.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- critically ill patients

- intubated

- mechanically ventilated

- 18 or older age

- enterally fed

Exclusion Criteria:

- prokinetic drugs before start study

- allergy to study medication

- interactions odf study medication with other drugs

- recent gastro-intestinal surgery

- history of esophagectomy or gastrectomy

- suspicion of gastrointestinal perforation

- myasthenia gravis

- liver dysfunction

- less than 7 days in study

- gastro- or jejunostomy

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium UZBrussels Jette

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

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