- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00916591
Prokinetic Drugs and Enteral Nutrition (prokinetics)
June 5, 2009 updated by: Universitair Ziekenhuis Brussel
Effect of Prokinetic Drugs During the Administration of Enteral Nutrition
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.
Study Overview
Status
Unknown
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jette, Belgium, 1090
- UZBrussels
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Critically ill patients, intubated and mechanically ventilated, 18 years or older
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Study Registration Dates
First Submitted
June 5, 2009
First Submitted That Met QC Criteria
June 5, 2009
First Posted (Estimate)
June 9, 2009
Study Record Updates
Last Update Posted (Estimate)
June 9, 2009
Last Update Submitted That Met QC Criteria
June 5, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UZBrussels
- 2009-012342-23
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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