N/A N=1,229 Randomized Treatment

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

End Stage Renal Disease (ESRD)

Bottom Line

View on ClinicalTrials.gov: NCT02604264 ↗

Enrolled (actual)

1,229

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days — 0.26; 0.59 PBCs per 1,000 CVC-days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ClearGuard HD end cap (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pursuit Vascular, Inc.
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days	0.26; 0.59	—

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.

Eligibility Criteria

Inclusion Criteria

All patients dialyzing with a central venous catheter

Exclusion Criteria

Known allergy to chlorhexidine

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Data sourced from ClinicalTrials.gov (NCT02604264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.