search
Back to results

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

Primary Purpose

Pancreatitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Erythromycin
Placebo
Sponsored by
Canisius-Wilhelmina Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring erythromycin, prokinetics, nasojejunal tubes, Bengmark feeding tube, post-pyloric feeding, pancreatitis, Non-critically ill patients having pancreatitis who require jejunal enteral nutrition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Erythromycin

    Placebo

    Arm Description

    Outcomes

    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

    Full Information

    First Posted
    October 20, 2009
    Last Updated
    January 21, 2010
    Sponsor
    Canisius-Wilhelmina Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00999232
    Brief Title
    Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Canisius-Wilhelmina Hospital

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatitis
    Keywords
    erythromycin, prokinetics, nasojejunal tubes, Bengmark feeding tube, post-pyloric feeding, pancreatitis, Non-critically ill patients having pancreatitis who require jejunal enteral nutrition

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    Erythromycin
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Erythromycin
    Intervention Description
    Subjects receive 4x250mg erythromycin i.v. daily after intubation of a self-propelled feeding tube
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Subjects receive 4x placebo i.v. daily after intubation of a self-propelled feeding tube
    Primary Outcome Measure Information:
    Title
    The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 48 hours.
    Secondary Outcome Measure Information:
    Title
    The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 24 hours.
    Title
    Adverse events using this self-propelled tube

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21447772
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs