NCT00916591

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
Last Updated

June 9, 2009

Status Verified

June 1, 2009

First QC Date

June 5, 2009

Last Update Submit

June 5, 2009

Conditions

Critically IllEnteral Nutrition

Keywords

gastroesophageal refluxrespiratory aspiration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • critically ill patients
  • intubated
  • mechanically ventilated
  • or older age
  • enterally fed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZBrussels

Jette, 1090, Belgium

Location

MeSH Terms

Conditions

Critical IllnessGastroesophageal RefluxRespiratory Aspiration

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesRespiration DisordersRespiratory Tract Diseases

Central Study Contacts

Nele Van De Winkel

CONTACT

00324773348nelevandewinkel@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 9, 2009

Study Start

September 1, 2009

Last Updated

June 9, 2009

Record last verified: 2009-06

Locations

BE(1)