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

NCT02593149 | Completed Results FDA Device

• 1 other identifier: CLP-0002
• Study Type: interventional
• Target: 1,902
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (1)

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

  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.

  Through the 13-month intervention period.

Study Arms (2)

Treatment

EXPERIMENTAL

ClearGuard HD End Cap

Device: ClearGuard HD End Cap

Control

NO INTERVENTION

Tego® connector with the CurosTM for Tego disinfecting port protector

Interventions

ClearGuard HD End Cap DEVICE

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients dialyzing with a central venous catheter

You may not qualify if:

• Known allergy to chlorhexidine

Sponsors & Collaborators

• Pursuit Vascular, Inc.: lead
• Davita Clinical Research: collaborator

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (1)

• 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.

  PMID: 29472415 RESULT

Related Links

• Pursuit Vascular website

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a pragmatic post market study. There was an informed consent waiver and no CRF's. Treatment arm adverse events during the 13-month intervention period were monitored using the FDA MAUDE database and none were reported.

Results Point of Contact

• Title: Laurie Lynch, PhD
• Organization: Pursuit Vascular, Inc.

llynch@pursuitvascular.com

6124249006

Study Officials

• Steven M Brunelli, MD, MSCE

  DaVita Clinical Research / DaVita HealthCare Partners

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: October 30, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 27, 2019
• Results First Posted: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)