Pediatric Ethanol Lock Therapy Study.

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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 blood stream infections (CRBSI) in each time period.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Calcium heparin; Ethanol; Heparin

Criteria

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