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

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ClinicalTrials.gov Identifier: NCT02593149
Recruitment Status : Completed
First Posted : October 30, 2015
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Davita Clinical Research
Information provided by (Responsible Party):
Pursuit Vascular, Inc.

Brief 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.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1902 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 : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: Treatment
ClearGuard HD End Cap
Device: ClearGuard HD End Cap
The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub

No Intervention: Control
Tego® connector with the CurosTM for Tego disinfecting port protector



Primary Outcome Measures :
  1. 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.




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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

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): NCT02593149


Locations
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United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Pursuit Vascular, Inc.
Davita Clinical Research
Investigators
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Principal Investigator: Steven M Brunelli, MD, MSCE DaVita Clinical Research / DaVita HealthCare Partners
Additional Information:
Publications of Results:
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Responsible Party: Pursuit Vascular, Inc.
ClinicalTrials.gov Identifier: NCT02593149    
Other Study ID Numbers: CLP-0002
First Posted: October 30, 2015    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019
Last Verified: February 2019
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