NCT02604264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,912

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 1, 2017

Completed
Last Updated

September 11, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

November 11, 2015

Results QC Date

March 21, 2017

Last Update Submit

August 13, 2018

Conditions

End Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (1)

  • Positive Blood Cultures (PBCs) 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.

    Up to 12 months

Study Arms (2)

ClearGuard HD end cap

ACTIVE COMPARATOR

Treatment

Device: ClearGuard HD end cap

Standard hemodialysis end cap

NO INTERVENTION

Control

Interventions

ClearGuard HD end capDEVICE

The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub

ClearGuard HD end cap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frenova Renal Research

Waltham, Massachusetts, 02541, United States

Location

Related Publications (2)

  • Hymes JL, Mooney A, Van Zandt C, Lynch L, Ziebol R, Killion D. Dialysis Catheter-Related Bloodstream Infections: A Cluster-Randomized Trial of the ClearGuard HD Antimicrobial Barrier Cap. Am J Kidney Dis. 2017 Feb;69(2):220-227. doi: 10.1053/j.ajkd.2016.09.014. Epub 2016 Nov 10.

    PMID: 27839894RESULT

  • Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.

    PMID: 35363884DERIVED

Related Links

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological 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 12-month intervention period were monitored using the FDA MAUDE database and none were reported.

Results Point of Contact

Title
Jeffrey L. Hymes, MD
Organization
Fresenius Medical Care North America
Jeffrey.HymesMD@fmc-na.com
615-567-4821

Study Officials

  • Jeffrey Hymes, MD

    Fresenius Medical Care North America

    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

November 11, 2015

First Posted

November 13, 2015

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

September 11, 2018

Results First Posted

May 1, 2017

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)