End Stage Renal Disease (ESRD)NCT02604264

Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap

A study testing ClearGuard HD end cap in people with End Stage Renal Disease (ESRD), run by Pursuit Vascular, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End Stage Renal Disease (ESRD)
What is being tested?: ClearGuard HD end cap
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,912 participants
Where: 1 siteUnited States
Study dates: Dec 2014to Nov 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients dialyzing with a central venous catheter

Who cannot join

Known allergy to chlorhexidine

Trial locations and contacts

1 site in 1 country.

United States1 site

Frenova Renal Research
Waltham, Massachusetts, 02541

Other trials in United States

About this study

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.

Conditions: End Stage Renal Disease (ESRD)
Being tested: ClearGuard HD end cap
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClearGuard HD end capDevice
The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub

Study groups in NCT02604264
Study group	Role	What they receive
ClearGuard HD end cap	Active comparator	Treatment Receives: Device: ClearGuard HD end cap
Standard hemodialysis end cap	No intervention	Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Nov 2015

First posted13 Nov 2015 (estimated)
Study startDec 2014
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,912 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02604264
Sponsor's protocol ID: CLP-0001
Status last verified: Jun 2018
First submitted: 11 Nov 2015
Last updated: 11 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 27839894
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.
PubMed 35363884

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End Stage Renal Disease (ESRD) trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
ClinicalTrials.gov ID: NCT02604264
Acronym / sponsor ID: CLP-0001
Conditions: End Stage Renal Disease (ESRD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,912 participants (actual)
Lead sponsor: Pursuit Vascular, Inc.Industry (pharma, biotech, devices)
Collaborators: Fresenius Medical Care North America
Study start: Dec 2014 (actual)
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 13 Nov 2015 (estimated)
Results: Posted 1 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ClearGuard HD end cap	Active comparator	Device: ClearGuard HD end capTreatment
Standard hemodialysis end cap	No intervention	–Control

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All patients dialyzing with a central venous catheter

Key exclusion criteria (1 listed)

Known allergy to chlorhexidine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ClearGuard HD end capThe ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub	Device	ClearGuard HD end cap

Primary outcome

Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days
Time frame: 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.

Results and safety

Results posted to the registry on 1 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	618	618
Control	611	611

Primary outcome: Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days

Time frame: Up to 12 months. Number. Unit: PBCs per 1,000 CVC-days

Measure	Treatment n = 1245	Control n = 1225
Value	0.26	0.59

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 1,245 (0%)	0 of 1,245 (0%)	134 of 1,245
Control	0 of 1,225 (0%)	0 of 1,225 (0%)	127 of 1,225

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27839894Hymes 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.
Derived from this study: PubMed 35363884Almeida 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.
Pursuit Vascular websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey Hymes, MD principal investigator

Fresenius Medical Care North America

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ClearGuard HD end cap in people with End Stage Renal Disease (ESRD), run by Pursuit Vascular, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02604264, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.