Back to resultsProduct Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
Primary Purpose
End Stage Renal Disease (ESRD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ClearGuard HD end cap
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease (ESRD)
Eligibility Criteria
Inclusion Criteria:
- All patients dialyzing with a central venous catheter
Exclusion Criteria:
- Known allergy to chlorhexidine
Sites / Locations
- Frenova Renal Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
ClearGuard HD end cap
Standard hemodialysis end cap
Arm Description
Treatment
Control
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02604264
First Posted
November 11, 2015
Last Updated
August 13, 2018
Sponsor
Pursuit Vascular, Inc.
Collaborators
Fresenius Medical Care North America
1. Study Identification
Unique Protocol Identification Number
NCT02604264
Brief Title
Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
Official Title
Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pursuit Vascular, Inc.
Collaborators
Fresenius Medical Care North America
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2912 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ClearGuard HD end cap
Arm Type
Active Comparator
Arm Description
Treatment
Arm Title
Standard hemodialysis end cap
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Device
Intervention Name(s)
ClearGuard HD end cap
Intervention Description
The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
Primary Outcome Measure Information:
Title
Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days
Description
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.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients dialyzing with a central venous catheter
Exclusion Criteria:
Known allergy to chlorhexidine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Hymes, MD
Organizational Affiliation
Fresenius Medical Care North America
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frenova Renal Research
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02541
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27839894
Citation
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.
Results Reference
result
PubMed Identifier
35363884
Citation
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.
Results Reference
derived
Links:
URL
http://www.pursuitvascular.com
Description
Pursuit Vascular website
Learn more about this trial
Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
We'll reach out to this number within 24 hrs