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| Name | Class |
|---|---|
| Fresenius Medical Care North America | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ClearGuard HD end cap | Active Comparator | Treatment |
|
| Standard hemodialysis end cap | No Intervention | Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearGuard HD end cap | Device | The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Hymes, MD | Fresenius Medical Care North America | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frenova Renal Research | Waltham | Massachusetts | 02541 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27839894 | Result | 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. | |
| 35363884 | Derived | 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. |
| Label | URL |
|---|---|
| Pursuit Vascular website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub |
| FG001 | Control | Standard hemodialysis end cap |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-In |
| |||||||||||||
| Intervention |
|
This is the intervention population data. The baseline data came from the 1 month run-in period prior to the start of the intervention period and is referred to as the run-in rather than baseline period. The run-in data was used to determine pre-study demographics and PBC rate.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub |
| BG001 | Control | Standard hemodialysis end cap |
| 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 (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. | Posted | Number | PBCs per 1,000 CVC-days | Up to 12 months |
|
1 year
The run-in data was used to determine pre-study demographics and PBC rate so no adverse event analysis was performed for the this period. 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 12-month intervention period using the FDA Manufacturer and User Facility Device Experience (MAUDE) database and none were reported.
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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: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter 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 12-month intervention period were monitored using the FDA MAUDE database and none were reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey L. Hymes, MD | Fresenius Medical Care North America | 615-567-4821 | Jeffrey.HymesMD@fmc-na.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 | Count of Participants | Participants |
|
ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub |
| OG001 | Control | Standard hemodialysis end cap |
|
|
| 134 |
| 1,245 |
| 0 |
| 1,245 |
| 0 |
| 1,245 |
| EG001 | Control | Standard hemodialysis end cap | 127 | 1,225 | 0 | 1,225 | 0 | 1,225 |
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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 |