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

August 13, 2018 updated by: Pursuit Vascular, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2912

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Waltham, Massachusetts, United States, 02541
        • Frenova Renal Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients dialyzing with a central venous catheter

Exclusion Criteria:

  • Known allergy to chlorhexidine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ClearGuard HD end cap
Treatment
Device: ClearGuard HD end cap
The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
No Intervention: Standard hemodialysis end cap
Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days
Time Frame: 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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pursuit Vascular, Inc.

Collaborators

Fresenius Medical Care North America

Investigators

  • Principal Investigator: Jeffrey Hymes, MD, Fresenius Medical Care North America

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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