Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube

This study has been completed.
Sponsor:
Information provided by:
Canisius-Wilhelmina Hospital
ClinicalTrials.gov Identifier:
NCT00999232
First received: October 20, 2009
Last updated: January 21, 2010
Last verified: October 2009
  Purpose

The purpose of this study is to assess the effect of erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube.


Condition Intervention Phase
Pancreatitis
Drug: Erythromycin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Canisius-Wilhelmina Hospital:

Primary Outcome Measures:
  • The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 48 hours.

Secondary Outcome Measures:
  • The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 24 hours.
  • Adverse events using this self-propelled tube

Study Start Date: October 2004
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erythromycin Drug: Erythromycin
Subjects receive 4x250mg erythromycin i.v. daily after intubation of a self-propelled feeding tube
Placebo Comparator: Placebo Drug: Placebo
Subjects receive 4x placebo i.v. daily after intubation of a self-propelled feeding tube

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-80 years
  • Having pancreatitis
  • Require jejunal enteral nutrition

Exclusion Criteria:

  • Known impaired peristalsis (critically ill patients, postoperative patients, history of surgery of the stomach/duodenum)
  • Pregnancy
  • Hypersensibility to erythromycin
  • Cardiac arrhythmias with a prolonged QT-time
  • Simultaneous usage of drugs impairing peristalsis
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Canisius-Wilhelmina Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00999232     History of Changes
Other Study ID Numbers: Bengmark_v1
Study First Received: October 20, 2009
Last Updated: January 21, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Canisius-Wilhelmina Hospital:
erythromycin
prokinetics
nasojejunal tubes
Bengmark feeding tube
post-pyloric feeding
pancreatitis
Non-critically ill patients having pancreatitis who require jejunal enteral nutrition

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Erythromycin stearate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 15, 2014