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

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ClinicalTrials.gov Identifier: NCT02604264
Recruitment Status : Completed
First Posted : November 13, 2015
Results First Posted : May 1, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Fresenius Medical Care North America
Information provided by (Responsible Party):
Pursuit Vascular, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease (ESRD) Device: ClearGuard HD end cap Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2912 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
Actual Study Start Date : December 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients dialyzing with a central venous catheter

Exclusion Criteria:

  • Known allergy to chlorhexidine
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604264


Locations
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United States, Massachusetts
Frenova Renal Research
Waltham, Massachusetts, United States, 02541
Sponsors and Collaborators
Pursuit Vascular, Inc.
Fresenius Medical Care North America
Investigators
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Principal Investigator: Jeffrey Hymes, MD Fresenius Medical Care North America
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Pursuit Vascular, Inc.
ClinicalTrials.gov Identifier: NCT02604264    
Other Study ID Numbers: CLP-0001
First Posted: November 13, 2015    Key Record Dates
Results First Posted: May 1, 2017
Last Update Posted: September 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency