Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap

Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days

This was calculated by dividing the cumulative number of PBCs by cumulative time at-risk as follows. The National Healthcare Safety Network (NHSN) Center for Disease Control (CDC) 21-day outpatient hemodialysis patient rule is as follows: A PBC is considered a new event and counted only if it occurred 21 days or more after a previously reported PBC in the same patient; new PBC events are based on blood cultures drawn as an outpatient or within one calendar day after a hospital admission. Following a PBC additional same-type events were counted beginning 21 days following the initial event; the CVC-days were counted during this period. The CVC-days were calculated by summing the number of days each patient was at-risk of accruing a PBC. This analysis included all subjects that participated in the study that were not otherwise censored to more accurately count CVC-days.

Time frame: Up to 12 months