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

Pancreatitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999232
• Other study ID #: Bengmark_v1
• Status: Completed
• Phase: Phase 4
• First received: October 20, 2009
• Last updated: January 21, 2010
• Start date: October 2004

Study information

• Verified date: October 2009
• Source: Canisius-Wilhelmina Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Drug:
• Erythromycin
Subjects receive 4x250mg erythromycin i.v. daily after intubation of a self-propelled feeding tube
• Placebo
Subjects receive 4x placebo i.v. daily after intubation of a self-propelled feeding tube

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Canisius-Wilhelmina Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 48 hours.
Secondary	The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 24 hours.
Secondary	Adverse events using this self-propelled tube