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Trial of 70% Ethanol Versus Heparin to Reduce the Rate of Central Line Infections in Children With Short Bowel Syndrome

NCT01263574 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-06-22

No results posted yet for this study

Summary

This study is designed to determine if the use of 70% ethanol lock solution in central lines decreases the rate of central line infections in children with short bowel syndrome. While ethanol locks have been used safely in children, there has been no published research to date that clearly shows it is of definite benefit in this group of patients.

Conditions

  • Catheter Related Infections
  • Short Bowel Syndrome

Interventions

DRUG

70% ethanol

Administration of the lock solution will occur between cycles of parenteral nutrition. Lock solutions will be administered three days per week. The pre-measured volume of lock solution will then be injected into the catheter for 4 hours. Prior to the next instillation of medications into the catheter, the lock solution will be aspirated and discarded. Another 5mL flush of saline will then be instilled into the catheter prior to medication or parenteral nutrition administration. Volume of lock solution administered will be determined by catheter size.

Sponsors & Collaborators

Principal Investigators

  • Tom Jaksic, M.D, Ph.D · Boston Children's Hospital

  • Christopher Duggan, M.D, MPH · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-06-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01263574 on ClinicalTrials.gov