Preliminary results of a phase I trial of prophylactic ethanol-lock administration to prevent mediport catheter-related bloodstream infections

预防性使用乙醇封管液预防输液港相关血流感染的I期临床试验初步结果

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Abstract

BACKGROUND: Catheter-related bloodstream infections remain costly with no simple prevention. We report preliminary results of a phase I trial of ethanol-lock administration to prevent mediport catheter-related bloodstream infections in children. METHODS: Twelve patients receiving intravenous antibody treatments for neuroblastoma were enrolled. On 4 days of each 5-day antibody cycle, 70% ethanol was administered instead of heparin to dwell in each patient's mediport overnight. We used clinical monitoring/questionnaires to assess symptoms and measured blood ethanol levels and liver functions. Patients were tracked for positive blood cultures. Time to infection for ethanol-lock-treated patients was compared with historical controls. RESULTS: We administered 123 ethanol-locks. No adverse symptoms attributable to ethanol occurred; one patient's urticaria worsened. Blood ethanol levels averaged 11 mg/dL. The study was voluntarily suspended after 3 patients' catheters became occluded, 1 of which fractured. A positive blood culture occurred in 1 (8%) of 12 patients, but suspension of the study precluded statistical power to detect impact on time to infection. CONCLUSIONS: Although children with mediport catheters exhibited nontoxic blood ethanol levels and a low rate of bloodstream infections following prophylactic ethanol-lock use, there was a high incidence of catheter occlusion. Adjustments are necessary before adopting ethanol-locks for routine prophylaxis against catheter infections in children.

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