Prokinetic Drugs and Enteral Nutrition (prokinetics)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00916591
Recruitment Status : Unknown
Verified June 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Not yet recruiting
First Posted : June 9, 2009
Last Update Posted : June 9, 2009
Information provided by:
Universitair Ziekenhuis Brussel

Brief 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.

Condition or disease
Critically Ill Enteral Nutrition

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
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Prokinetic Drugs During the Administration of Enteral Nutrition
Study Start Date : September 2009

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients, intubated and mechanically ventilated, 18 years or older

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00916591

Contact: Nele Van De Winkel 00324773348

UZBrussels Not yet recruiting
Jette, Belgium, 1090
Contact: Nele Van De Winkel, MD    00324773348   
Principal Investigator: Nele Van De Winkel, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel

Responsible Party: Van De Winkel Nele MD, UZBrussels Identifier: NCT00916591     History of Changes
Other Study ID Numbers: UZBrussels
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: June 9, 2009
Last Verified: June 2009

Keywords provided by Universitair Ziekenhuis Brussel:
gastroesophageal reflux
respiratory aspiration

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes