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

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.

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Key information

Conditions

End Stage Renal Disease (ESRD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients dialyzing with a central venous catheter

Exclusion criteria

Known allergy to chlorhexidine

Treatment and study plan

ClearGuard HD End Cap

Device

The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub

Primary outcomes

Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pursuit Vascular, Inc.

Industry

Collaborators

Davita Clinical Research

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 30, 2015
Registry last updated: Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed