| Registry | NCT02604264 |
|---|
| Status | Completed |
|---|
| Phase | Not applicable |
|---|
| Study type | Interventional; randomized, parallel, masking: none, treatment |
|---|
| Enrollment | 2912 (Actual) |
|---|
| Sponsor | Pursuit Vascular, Inc. (Industry); collaborators: Fresenius Medical Care North America |
|---|
| Conditions | End Stage Renal Disease (ESRD) |
|---|
| Interventions | ClearGuard HD end cap (Device) |
|---|
| Dates | start 2014-12-01, primary completion 2015-11-01, completion 2015-11-01, first posted 2015-11-13, last updated 2018-09-11 |
|---|
| Locations | 1 site in United States |
|---|
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for End Stage Renal Disease (ESRD) All trials of ClearGuard HD end cap
-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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| ClearGuard HD end cap | Active comparator | Device: ClearGuard HD end cap | Treatment |
| Standard hemodialysis end cap | No intervention | | Control |
- ClearGuard HD end cap (Device): The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
+Outcome measures
Primary outcomes
- Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days [Up to 12 months]: 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.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* All patients dialyzing with a central venous catheter
Exclusion Criteria:
* Known allergy to chlorhexidine
+Posted results
Participant flow
| Milestone | Treatment | Control |
|---|
| Started | 618 | 611 |
| Completed | 618 | 611 |
| Not completed | 0 | 0 |
Outcome results
- Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days (Primary), Number, PBCs per 1,000 CVC-days: Treatment 0.26; Control 0.59
Adverse events
Time frame: 1 year
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Treatment | 134/1245 (10.8%) | 0/1245 (0.0%) | 0/1245 (0.0%) |
| Control | 127/1225 (10.4%) | 0/1225 (0.0%) | 0/1225 (0.0%) |
Limitations and caveats: 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.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Frenova Renal Research | Waltham, Massachusetts | United States | |
+Publications
- Results publication: 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. PMID 27839894
- Results publication: 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. PMID 35363884
+Investigators