Pediatric Ethanol Lock Therapy Study.

Completed · Not applicable · Has a placebo group

Conditions studied: Catheter-Related Infections

In brief

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.

Key facts

Study ID

NCT00948441

Run by

University of Pittsburgh

People needed

16

Starts

2008-08-01

Expected to finish

2014-12-01

Last updated by the study team

2016-04-18

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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