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
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.

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 July 22, 2014