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

Not Applicable

Completed

• Conditions: End Stage Renal Disease (ESRD)
• Interventions: Device: ClearGuard HD End Cap

• Registration Number: NCT02593149
• Lead Sponsor: Pursuit Vascular, Inc.

Brief Summary

To assess blood stream infections in participants using two FDA-cleared devices: ClearGuard HD end caps compared to the Tego® connector with the CurosTM for Tego disinfecting port protector.

Detailed Description

Prospective, cluster-randomized, open-label, post market, comparative effectiveness evaluation with facilities participating for up to 13 months.

Study Timeline

• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Study Start: 2015-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2018-06-29
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-05
• Last Update Submitted: 2019-02-05
• Results First Posted: 2019-02-27
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1902

Inclusion Criteria

• All patients dialyzing with a central venous catheter

Exclusion Criteria

• Known allergy to chlorhexidine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	ClearGuard HD End Cap	ClearGuard HD End Cap

Primary Outcome Measures

Name	Time	Method
Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days	Through the 13-month intervention period.	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.

Trial Locations

Locations (1)

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States