Prokinetic Drugs and Enteral Nutrition | NCT00916591

Studies
Prokinetic Drugs and Enteral Nutrition

NCT00916591

Sponsor

Universitair Ziekenhuis Brussel

Status

Unknown status

Last Update Posted

Jun 9, 2009Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Critically Ill
Enteral Nutrition

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-012342-23

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 5, 2009

First Submission Date that Met QC Criteria

Jun 5, 2009

First Posted Date

Jun 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2009

Last Update Posted Date

Jun 9, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nele Van De Winkel	Contact	00324773348		nelevandewinkel@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZBrussels		Jette		1090	Belgium	Nele Van De Winkel, MD

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D005764	Gastroesophageal Reflux
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D015154	Esophageal Motility Disorders

Browse Leaves

Not provided

Browse Branches

Not provided