- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01263574
Trial of 70% Ethanol Versus Heparin to Reduce the Rate of Central Line Infections in Children With Short Bowel Syndrome
June 20, 2017 updated by: Tom Jaksic, Boston Children's Hospital
Trial of Ethanol Lock Therapy to Prevent Catheter Associated Blood Stream Infections
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age >3 months
- Intestinal failure patients
- Silicone catheter for the administration of parenteral nutrition
Exclusion Criteria:
- Age < 3 months
- Weight < 5 kg
- Documented allergy to ethanol
- Evidence of tunnel site infection
- Patients receiving continuous renal replacement therapy
- Concomitant use of metronidazole
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Heparinized Saline
This group will maintain their central lines patent with heparinized saline.
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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.
Other Names:
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Experimental: Ethanol lock solution group
Administration of the 70% ethanol lock solution will occur between cycles of parenteral nutrition.
Randomized lock solutions will be administered three days per week.
When patients have completed their parenteral nutrition, their central venous catheters will be flushed with 5mL saline, per current standards
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Catheter associated blood stream infection (CABSI).
Time Frame: Number of infections reported per 1000 catheter days.
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Published data in intensive care unit (ICU) patients with CABSI has noted that central venous catheter cultures had a specificity of 98% and a negative predictive value of 97%.
In our study, we will define CABSI as a positive central venous catheter blood culture in the face of clinical signs of infection, when the catheter has been used in the last 48 hours prior to infection, and without other obvious source of infection.
CABSI rate will be reported as number of infections per 1000 catheter days after 12 months of follow up.
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Number of infections reported per 1000 catheter days.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tom Jaksic, M.D, Ph.D, Boston Children's Hospital
- Principal Investigator: Christopher Duggan, M.D, MPH, Boston Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2011
Primary Completion (Anticipated)
June 1, 2012
Study Completion (Anticipated)
September 1, 2012
Study Registration Dates
First Submitted
December 17, 2010
First Submitted That Met QC Criteria
December 17, 2010
First Posted (Estimate)
December 20, 2010
Study Record Updates
Last Update Posted (Actual)
June 22, 2017
Last Update Submitted That Met QC Criteria
June 20, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Postoperative Complications
- Disease Attributes
- Disease
- Gastrointestinal Diseases
- Intestinal Diseases
- Malabsorption Syndromes
- Syndrome
- Infections
- Communicable Diseases
- Catheter-Related Infections
- Short Bowel Syndrome
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Ethanol
Other Study ID Numbers
- 09-03-0132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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