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

End Stage Renal Disease (ESRD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593149
• Other study ID #: CLP-0002
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: February 2019
• Source: Pursuit Vascular, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1902
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients dialyzing with a central venous catheter

Exclusion Criteria:

• Known allergy to chlorhexidine

Related Conditions & MeSH terms

• End Stage Renal Disease (ESRD)
• Kidney Failure, Chronic

Intervention

Device:
• ClearGuard HD End Cap
The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub

Locations

Country	Name	City	State
United States	DaVita Clinical Research	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Pursuit Vascular, Inc.	Davita Clinical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brunelli SM, Van Wyck DB, Njord L, Ziebol RJ, Lynch LE, Killion DP. Cluster-Randomized Trial of Devices to Prevent Catheter-Related Bloodstream Infection. J Am Soc Nephrol. 2018 Apr;29(4):1336-1343. doi: 10.1681/ASN.2017080870. Epub 2018 Feb 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Blood Cultures (PBC's) 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.	Through the 13-month intervention period.

External Links

•   Pursuit Vascular website