Pediatric Ethanol Lock Therapy Study.

Not Applicable

Completed

• Conditions: Catheter-Related Infections
• Interventions: Drug: 25% ethanol; Other: heparin lock

• Registration Number: NCT00948441
• Lead Sponsor: University of Pittsburgh

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 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 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 have a critical need to maintain vascular access, lock therapy with a solution of 25% ethanol has been suggested to prevent future CRBSI. There is sufficient data to suggest that this combination is likely to be effective, is unlikely to lead to the development of multidrug resistant organisms and is well tolerated. Our hypothesis is that the use of ethanol as a lock therapy can reduce the number of CRBSI in both pre and post transplant patients with intestinal insufficiency.

Specific Aim: To compare the number of CRBSI in patients who receive ethanol lock therapy with the number of infections while on placebo lock therapy with heparin. This will be accomplished by conducting a prospective cross-over, double blind, placebo controlled study in children who have intestinal insufficiency and a history of multiple CRBSIs. Each child will receive 3 months of study lock therapy (25% ethanol) and 3 months of placebo lock therapy (heparin). The investigators, the patient and their family will be blinded to the treatment. The primary outcome measure will be the number of CRBSIs. Patients will also be observed for possible side effects from the therapy, and the need for line removal. This pilot study should provide preliminary data and information regarding the feasibility for a larger, multi-center study of ethanol lock therapy for the prevention of CRBSI.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-29
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-02-19
• Results First Submitted QC: 2016-02-19
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-18
• Results First Posted: 2016-03-21
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	25% ethanol	25% ethanol for 12 weeks; wash out period for 4 weeks; heparin lock for 12 weeks
Group 2	25% ethanol	heparin lock for 12 weeks; wash out period for 4 weeks; 25% ethanol lock for 12 weeks
Group 1	heparin lock	25% ethanol for 12 weeks; wash out period for 4 weeks; heparin lock for 12 weeks
Group 2	heparin lock	heparin lock for 12 weeks; wash out period for 4 weeks; 25% ethanol lock for 12 weeks

Primary Outcome Measures

Name	Time	Method
Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period.	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.

Secondary Outcome Measures

Name	Time	Method
Safety, Side Effects	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.

Trial Locations

Locations (1)

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States