Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
- Conditions
- End Stage Renal Disease (ESRD)
- Interventions
- Device: ClearGuard HD end cap
- Registration Number
- NCT02604264
- Lead Sponsor
- Pursuit Vascular, Inc.
- Brief Summary
To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC) patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end caps.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2912
- All patients dialyzing with a central venous catheter
- Known allergy to chlorhexidine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ClearGuard HD end cap ClearGuard HD end cap Treatment
- Primary Outcome Measures
Name Time Method Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days Up to 12 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Frenova Renal Research
🇺🇸Waltham, Massachusetts, United States