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

History of Changes

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:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Pancreatitis

Drug Information available for: Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erythromycin phosphate

U.S. FDA Resources

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):

van den Bosch S, Witteman E, Kho Y, Tan AC. Erythromycin to promote bedside placement of a self-propelled nasojejunal feeding tube in non-critically ill patients having pancreatitis: a randomized, double-blind, placebo-controlled study. Nutr Clin Pract. 2011 Apr;26(2):181-5.

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 May 19, 2013

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