Prokinetic Drugs and Enteral Nutrition (prokinetics)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00916591
First received: June 5, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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
Critically Ill
Enteral Nutrition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Prokinetic Drugs During the Administration of Enteral Nutrition

Further study details as provided by Universitair Ziekenhuis Brussel:

Estimated Enrollment: 60
Study Start Date: September 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Critically ill patients, intubated and mechanically ventilated, 18 years or older

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916591

Contacts
Contact: Nele Van De Winkel 00324773348 nelevandewinkel@hotmail.com

Locations
Belgium
UZBrussels Not yet recruiting
Jette, Belgium, 1090
Contact: Nele Van De Winkel, MD    00324773348    nelevandewinkel@hotmail.com   
Principal Investigator: Nele Van De Winkel, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
  More Information

No publications provided

Responsible Party: Van De Winkel Nele MD, UZBrussels
ClinicalTrials.gov Identifier: NCT00916591     History of Changes
Other Study ID Numbers: UZBrussels, 2009-012342-23
Study First Received: June 5, 2009
Last Updated: June 5, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitair Ziekenhuis Brussel:
gastroesophageal reflux
respiratory aspiration

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014