NCT00999232

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
Last Updated

January 22, 2010

Status Verified

October 1, 2009

Enrollment Period

2.7 years

First QC Date

October 20, 2009

Last Update Submit

January 21, 2010

Conditions

Pancreatitis

Keywords

erythromycinprokineticsnasojejunal tubesBengmark feeding tubepost-pyloric feedingpancreatitisNon-critically ill patients having pancreatitis who require jejunal enteral nutrition

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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 Arms (2)

Erythromycin

EXPERIMENTAL
Drug: Erythromycin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ErythromycinDRUG

Subjects receive 4x250mg erythromycin i.v. daily after intubation of a self-propelled feeding tube

Erythromycin
PlaceboDRUG

Subjects receive 4x placebo i.v. daily after intubation of a self-propelled feeding tube

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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. doi: 10.1177/0884533611399924.

    PMID: 21447772DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Erythromycin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

October 1, 2004

Primary Completion

July 1, 2007

Last Updated

January 22, 2010

Record last verified: 2009-10