End Stage Renal Disease (ESRD)
Conditions
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.
Detailed description
Prospective, cluster-randomized, open-label, post market, comparative effectiveness evaluation with facilities participating for up to 13 months.
Interventions
DEVICEClearGuard HD End Cap
The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub
Sponsors
Davita Clinical Research
Pursuit Vascular, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients dialyzing with a central venous catheter
Exclusion criteria
* Known allergy to chlorhexidine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days | Through the 13-month intervention period. | 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. |
Countries
United States
Participant flow
Pre-assignment details
Baseline characteristic data were not collected for the participants in the Intervention Period. Baseline data were collected for the Run-In Period with the a priori intent of showing that baseline characteristics were similar in both arms. 9 patients were excluded due to heparin allergies prior to enrollment during the Intervention period.
Participants by arm
| Arm | Count |
|---|---|
| Treatment ClearGuard HD End Cap
ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub | 304 |
| Control Tego® connector with the CurosTM for Tego disinfecting port protector | 323 |
| Total | 627 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Intervention | Didn't use CVC for at least 21 day | 116 | 115 |
| Run-In | Didn't use CVC for at least 21 days | 36 | 38 |
Baseline characteristics
| Characteristic | Treatment | Total | Control |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 15.6 | 62.9 years STANDARD_DEVIATION 15.6 | 62.2 years STANDARD_DEVIATION 15.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 37 Participants | 73 Participants | 36 Participants |
| Race (NIH/OMB) Black or African American | 107 Participants | 256 Participants | 149 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants | 37 Participants | 13 Participants |
| Race (NIH/OMB) White | 133 Participants | 255 Participants | 122 Participants |
| Region of Enrollment United States | 304 participants | 627 participants | 323 participants |
| Sex: Female, Male Female | 159 Participants | 319 Participants | 160 Participants |
| Sex: Female, Male Male | 145 Participants | 308 Participants | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 826 | 0 / 845 |
| other Total, other adverse events | 0 / 826 | 0 / 845 |
| serious Total, serious adverse events | 0 / 826 | 0 / 845 |
Outcome results
Primary
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.
Time frame: Through the 13-month intervention period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days | 0.28 PBCs per 1,000 CVC-days |
| Control | Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days | 0.75 PBCs per 1,000 CVC-days |