Pediatric Ethanol Lock Therapy Study.
Condition: Catheter-Related Infections
MeSH terms: Infections; Catheter-Related Infections
Study type: Interventional

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.
    

Intervention name(s): 25% ethanol; heparin lock
Intervention type(s): Drug; Other
Intervention description(s): Study Lock -25% Ethanol- The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day.; Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours.
Other intervention name(s): ethanol
Intervention MeSH terms: Ethanol; Heparin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: intestinal insufficiency; central venous catheter; Catheter-Related Infections; pediatrics; ethanol