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| Name | Class |
|---|---|
| Davita Clinical Research | INDUSTRY |
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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.
Prospective, cluster-randomized, open-label, post market, comparative effectiveness evaluation with facilities participating for up to 13 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | ClearGuard HD End Cap |
|
| Control | No Intervention | Tego® connector with the CurosTM for Tego disinfecting port protector |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearGuard HD End Cap | Device | The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven M Brunelli, MD, MSCE | DaVita Clinical Research / DaVita HealthCare Partners | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29472415 | Result | 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. |
| Label | URL |
|---|---|
| Pursuit Vascular website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | ClearGuard HD End Cap ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub |
| FG001 | Control | Tego® connector with the CurosTM for Tego disinfecting port protector |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-In |
|
| ||||||||||||||||||
| Intervention |
|
Baseline characteristic data were not collected for the participants in the "Intervention" Period. Baseline data were collected during the "Run-In" Period with the a priori intent of demonstrating that baseline characteristics are generally balanced for the participants coming in for treatment."
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | ClearGuard HD End Cap ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub |
| BG001 | Control | Tego® connector with the CurosTM for Tego disinfecting port protector |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | PBCs per 1,000 CVC-days | Through the 13-month intervention period. |
|
13 months
The run-in data was used to determine pre-study demographics and PBC rate. No adverse event analysis was performed for this period since these patients were not enrolled in the study. This was a pragmatic post market study. There was an informed consent waiver and there were no study case report forms (CRF's). Treatment arm adverse events were monitored during the 13-month intervention period using the FDA Manufacturer and User Facility Device Experience (MAUDE) database.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | ClearGuard HD End Cap ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laurie Lynch, PhD | Pursuit Vascular, Inc. | 6124249006 | llynch@pursuitvascular.com |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Treatment |
ClearGuard HD End Cap ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub |
| OG001 | Control | Tego® connector with the CurosTM for Tego disinfecting port protector |
|
|
| 0 |
| 826 |
| 0 |
| 826 |
| 0 |
| 826 |
| EG001 | Control | Tego® connector with the CurosTM for Tego disinfecting port protector | 0 | 845 | 0 | 845 | 0 | 845 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |