Status:
COMPLETED
Pediatric Ethanol Lock Therapy Study.
Lead Sponsor:
University of Pittsburgh
Conditions:
Catheter-Related Infections
Eligibility:
All Genders
6-21 years
Phase:
NA
Brief Summary
This study is a double-blind crossover design to compare prophylaxis with ethanol lock therapy versus placebo lock therapy (heparin). The primary outcome measure will be the number of catheter related...
Detailed Description
Central venous catheters (CVCs) are crucial for patients who require long term vascular access due to a variety of underlying diseases. Children with intestinal insufficiency and other diseases requir...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- patients with central venous access and a history of three or more CRBSI in the prior 6 months
- age greater than 6 months
- anticipation for the need for continued central venous access over the next 7 months
- availability to come for a monthly study visit
- anticipation that the patient will receive medical care at Children's Hospital of Pittsburgh for the majority of the CRBSI which occur during the next 7 months and the ability to lock the central venous catheter for a minimum of 4 hours per day
- Exclusion criteria:
- age less than 6 months and greater than or equal to 21 years
- known immunodeficiency (with the exception of immunosuppression in a patient after organ transplantation)
- known allergy or intolerance to ethanol or heparin lock therapy
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00948441
Start Date
August 1 2008
End Date
December 1 2014
Last Update
April 18 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15201