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

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ClinicalTrials.gov Identifier: NCT00999232
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : January 22, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatitis Drug: Erythromycin Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2004
Primary Completion Date : July 2007


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
More Information

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
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: October 2009

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
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action