Clinical Trial: Pediatric Ethanol Lock Therapy Study.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ethanol Lock Therapy for the Prevention of Catheter Related Blood Stream Infections

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 blood stream infections (CRBSI) in each time period.

Detailed Summary:

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 require vascular access to receive total parenteral nutrition, chemotherapy, fluid support and for the convenience of avoiding peripheral sticks when multiple blood draws are required. While these catheters have many benefits, they are also associated with complications such as catheter-related bloodstream infections (CRBSI). These infections can be a major cause of morbidity, mortality, and increased health care costs. Coagulase-negative staphylococci, Staphylococcus aureus, aerobic gram-negative bacilli, and Candida species (especially albicans) are the most common organisms responsible for these infections. These infections are traditionally treated with systemic antimicrobial therapy. There are times when the catheter must be removed to adequately treat the infection, however, indications for catheter removal in children are controversial. For some children with a history of multiple line infections, there are limited sites available to place new vascular access when the CVC needs to be replaced. Reducing the number of infections in this group of children is highly desirable. The goal of this study is to improve patient outcomes by reducing the risk of infection, thereby decreasing waitlist morbidity and mortality and improving post transplant care.

Lock therapy is the procedure of allowing medications to dwell in the line for extended periods of time without interruption. Many different agents such as ethanol, vancomycin and gentamicin have been used successfully as a means to salvage a CVC that has become infected. There is limited information regarding the use of lock therapy to prevent CRBSI in patients with CVCs. However, in patients with a history of multiple CRBSI, who h
Sponsor: University of Pittsburgh

Current Primary Outcome: Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period. [ Time Frame: 7 months per study patient ]

For the purpose of this study, episodes of catheter related blood stream infections were considered as the primary outcome measure. An episode of infection was defined as more than one positive blood culture obtained from the catheter requiring antibiotic therapy. Each episode after enrollment was recorded in its appropriate study period: ethanol lock, placebo lock, or washout period. If a patient had a catheter related blood stream infections, the study locks were held until after the number of days in each period was calculated as the number of days not on antibiotic therapy.


Original Primary Outcome: Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period. [ Time Frame: 7 months per study patient ]

Current Secondary Outcome: Safety, Side Effects [ Time Frame: 7 months per study patient ]

collection of adverse events and safety information. Each participant was contacted either at a clinical visit or by phone every two weeks while enrolled in the study.


Original Secondary Outcome: Safety, Side Effects [ Time Frame: 7 months per study patient ]

Information By: University of Pittsburgh

Dates:
Date Received: July 7, 2009
Date Started: August 2008
Date Completion:
Last Updated: March 18, 2016
Last Verified: March 2016