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

NCT ID: NCT02593149

Last Updated: 2019-02-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1902 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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

Conditions

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End Stage Renal Disease (ESRD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

ClearGuard HD End Cap

Group Type EXPERIMENTAL

ClearGuard HD End Cap

Intervention Type DEVICE

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

Control

Tego® connector with the CurosTM for Tego disinfecting port protector

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ClearGuard HD End Cap

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients dialyzing with a central venous catheter

Exclusion Criteria

* Known allergy to chlorhexidine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Davita Clinical Research

INDUSTRY

Sponsor Role collaborator

Pursuit Vascular, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven M Brunelli, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

DaVita Clinical Research / DaVita HealthCare Partners

Locations

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DaVita Clinical Research

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Brunelli SM, Van Wyck DB, Njord L, Ziebol RJ, Lynch LE, Killion DP. Cluster-Randomized Trial of Devices to Prevent Catheter-Related Bloodstream Infection. J Am Soc Nephrol. 2018 Apr;29(4):1336-1343. doi: 10.1681/ASN.2017080870. Epub 2018 Feb 22.

Reference Type RESULT
PMID: 29472415 (View on PubMed)

Related Links

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http://pursuitvascular.com

Pursuit Vascular website

Other Identifiers

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CLP-0002

Identifier Type: -

Identifier Source: org_study_id

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