Trial Outcomes & Findings for Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap (NCT NCT02604264)
NCT ID: NCT02604264
Last Updated: 2018-09-11
Results Overview
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.
COMPLETED
NA
2912 participants
Up to 12 months
2018-09-11
Participant Flow
Participant milestones
| Measure |
Treatment
ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
|
Control
Standard hemodialysis end cap
|
|---|---|---|
|
Run-In
STARTED
|
618
|
611
|
|
Run-In
COMPLETED
|
618
|
611
|
|
Run-In
NOT COMPLETED
|
0
|
0
|
|
Intervention
STARTED
|
1445
|
1467
|
|
Intervention
COMPLETED
|
1245
|
1225
|
|
Intervention
NOT COMPLETED
|
200
|
242
|
Reasons for withdrawal
| Measure |
Treatment
ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
|
Control
Standard hemodialysis end cap
|
|---|---|---|
|
Intervention
Didn't use CVC for at least 21 days
|
200
|
242
|
Baseline Characteristics
Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
Baseline characteristics by cohort
| Measure |
Treatment
n=1245 Participants
ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
|
Control
n=1225 Participants
Standard hemodialysis end cap
|
Total
n=2470 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 15.1 • n=99 Participants
|
60.6 years
STANDARD_DEVIATION 15.1 • n=107 Participants
|
61.1 years
STANDARD_DEVIATION 15.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
591 Participants
n=99 Participants
|
559 Participants
n=107 Participants
|
1150 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
654 Participants
n=99 Participants
|
666 Participants
n=107 Participants
|
1320 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
566 Participants
n=99 Participants
|
495 Participants
n=107 Participants
|
1061 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
609 Participants
n=99 Participants
|
631 Participants
n=107 Participants
|
1240 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
53 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1245 Participants
n=99 Participants
|
1225 Participants
n=107 Participants
|
2470 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsThis 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.
Outcome measures
| Measure |
Treatment
n=1245 Participants
ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
|
Control
n=1225 Participants
Standard hemodialysis end cap
|
|---|---|---|
|
Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days
|
0.26 PBCs per 1,000 CVC-days
|
0.59 PBCs per 1,000 CVC-days
|
Adverse Events
Treatment
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey L. Hymes, MD
Fresenius Medical Care North America
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place