End Stage Renal DiseaseNCT02453646
Analysis of CRBSI Rates in Patients With a NexSite™ HD (Hemodialysis) Catheter
A study testing NexSite HD Patients in people with End Stage Renal Disease, run by Marvao Medical at 6 sites in United States.
Trial summary
A U.S. multi-centre post approval registry to analyse the CRBSI rate in patients with the NexSite HD Catheter for long term vascular access for hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- NexSite HD Patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient shall be 18 - 80 years old.
- The patient requires the placement of a long term tunnelled HD catheter for administration of hemodialysis.
- The patient has anticipated survival in excess of 90 days from the anticipated date of catheter placement.
- The patient has the ability to understand the research subject information and sign a written Informed Consent form which must be obtained prior to initiation of the study.
- The patient receives the catheter via the internal jugular or subclavian vein.
- All female patients of child bearing potential must complete a negative pregnancy test and will confirm that they are not breastfeeding.
Who cannot join
- The patient is participating in another IRB (Institutional Review Board) clinical trial, which modifies standard-of-care treatment and/or involves an investigational device or drug.
- The patient has a confirmed or suspected infection, bacteraemia or septicaemia.
- The patient's physiology is NOT suitable for placement of the NexSite device; this will include an examination of the anatomy at the proposed catheter exit site.
- The patient is known or suspected to have allergies to the materials used in the construction of the device.
- The patient has previously suffered from coagulation issues or has had vascular surgery at the proposed placement site.
- The patient has received radiation treatment at the proposed catheter placement site.
Show all 18Show fewer
- The patient has severe chronic obstructive lung disease.
- The patient is pyretic within 72 hours (temperature ≥38o C or 100.4oF) prior to placement and/or has received antimicrobial drugs within two weeks prior to catheterisation.
- The patient is female of child bearing potential not using adequate contraception. (Adequate contraception is defined as abstinence, intrauterine device [IUD], birth control pills, or spermicidal gel with diaphragm or condom)
- The patient has another indwelling catheter.
- The patient has non-healing diabetic foot ulcers.
- The patient did not give informed consent.
- The patient would be unavailable for follow-up.
- The patient is a permanent nursing home resident.
- The proposed access site is not the internal jugular or subclavian vein.
- The patient is scheduled to undergo an elective surgical procedure (other than a procedure to create a graft or fistula) within the study timeframe.
- Any other condition that the Investigator believes should exclude the patient from the study.
- The patient does not have English or Spanish as their first language.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Eastern Nephrology Associates
Greenville, North Carolina, 27834
Lubbock Vascular Access Centre
Lubbock, Texas, 79416
Eastern Nephology Associates
New Bern, North Carolina, 28542
South Carolina Nephrology and Hypertension Center Inc
Orangeburg, South Carolina, 29118
Capital Nephrology Associates
Raleigh, North Carolina, 27610
Renal Associates
San Antonio, Texas, 78215
About this study
Official title: Analysis of CRBSI (Catheter-Related Blood Stream Infection) Rates in Patients With a NexSite™ HD (Hemodialysis) Catheter
A U.S. multi-centre post approval registry to analyse the CRBSI rate in patients with the NexSite HD Catheter for long term vascular access for hemodialysis.
Read the detailed description
This is a U.S. multi - centre, prospective, non-randomized post approval registry. Approximately one hundred and twenty patients will be implanted with a NexSite HD catheter at four to eight U.S. sites where hemodialysis catheters are routinely implanted. Each site may enrol a maximum of 50 patients. Enrolled patients will be followed from device placement to device removal or 180 days post device placement. Patients will be enrolled once only.
The primary endpoint is CRBSI rate related to the NexSite HD catheter. Determination of infection will be decided by the investigator and if necessary adjudicated by the CEC (Clinical Events Committee) based on blood culture results, regardless of whether the catheter is removed.
Secondary endpoints for the study are
- Successful placement and continued use of the NexSite HD device designed for use in patients requiring long term hemodialysis.
- Healing of catheter exit site
- Tunnel Infections
- Exit site infections
- Early non-infectious complications associated with CVCs
- Late non-infectious complications associated with Central Venous Catheters
- Conditions
- End Stage Renal Disease
- Being tested
- NexSite HD Patients
- 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.
NexSite HD PatientsDevice
Measurement of CRBSI rate and other device related adverse events in patients with NexSite HD Catheter.
| Study group | Role | What they receive |
|---|---|---|
| NexSite HD Patients | Experimental | NexSite HD patient catheter device placement Receives: Device: NexSite HD Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Catheter-Related Blood Stream Infection (CRBSI)(bacteremia/fungemia) as an adverse event.
Number of participants with a confirmed CRBSI for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Measured: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Secondary outcomes (6)
Number of participants with adverse events associated with device placement and use.
Number of participants with adverse events associated with device placement and for the duration of catheter use or to 180 days post device placement.
Measured: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with unhealed catheter exit sites
Number of participants with unhealed exit sites for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Measured: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with tunnel infection as an adverse event
Number of participants with a tunnel infection for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Measured: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with exit site infection as an adverse event
Number of participants with a exit site infection for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Measured: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with Pneumothorax, haemothorax, arrhythmia, air embolism or arterial perforation as an adverse event.
Number of participants with non-infectious catheter complications within one day of placement.
Measured: 1 day of device placement
Number of participants with Catheter dislodgement, Catheter tip dislodgement and catheter thrombosis as an adverse event.
Number of participants with late non infectious complications for the duration of catheter use or to 180 days post device placement (whichever occurs first).
Measured: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marvao Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey G Hoggard, MD, Principal investigator, Capital Nephrology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453646
- Sponsor's protocol ID
- TR 0147
- Status last verified
- Sep 2018
- First submitted
- 18 May 2015
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of CRBSI (Catheter-Related Blood Stream Infection) Rates in Patients With a NexSite™ HD (Hemodialysis) Catheter
- ClinicalTrials.gov ID
- NCT02453646
- Acronym / sponsor ID
- TR 0147
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Marvao MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A U.S. multi-centre post approval registry to analyse the CRBSI rate in patients with the NexSite HD Catheter for long term vascular access for hemodialysis.
Detailed description
This is a U.S. multi - centre, prospective, non-randomized post approval registry. Approximately one hundred and twenty patients will be implanted with a NexSite HD catheter at four to eight U.S. sites where hemodialysis catheters are routinely implanted. Each site may enrol a maximum of 50 patients. Enrolled patients will be followed from device placement to device removal or 180 days post device placement. Patients will be enrolled once only.
The primary endpoint is CRBSI rate related to the NexSite HD catheter. Determination of infection will be decided by the investigator and if necessary adjudicated by the CEC (Clinical Events Committee) based on blood culture results, regardless of whether the catheter is removed.
Secondary endpoints for the study are
- Successful placement and continued use of the NexSite HD device designed for use in patients requiring long term hemodialysis.
- Healing of catheter exit site
- Tunnel Infections
- Exit site infections
- Early non-infectious complications associated with CVCs
- Late non-infectious complications associated with Central Venous Catheters
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NexSite HD Patients | Experimental | Device: NexSite HD PatientsNexSite HD patient catheter device placement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient shall be 18 - 80 years old.
- The patient requires the placement of a long term tunnelled HD catheter for administration of hemodialysis.
- The patient has anticipated survival in excess of 90 days from the anticipated date of catheter placement.
- The patient has the ability to understand the research subject information and sign a written Informed Consent form which must be obtained prior to initiation of the study.
- The patient receives the catheter via the internal jugular or subclavian vein.
Key exclusion criteria (18 listed)
- The patient is participating in another IRB (Institutional Review Board) clinical trial, which modifies standard-of-care treatment and/or involves an investigational device or drug.
- The patient has a confirmed or suspected infection, bacteraemia or septicaemia.
- The patient's physiology is NOT suitable for placement of the NexSite device; this will include an examination of the anatomy at the proposed catheter exit site.
- The patient is known or suspected to have allergies to the materials used in the construction of the device.
- The patient has previously suffered from coagulation issues or has had vascular surgery at the proposed placement site.
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 |
|---|---|---|
| NexSite HD PatientsMeasurement of CRBSI rate and other device related adverse events in patients with NexSite HD Catheter. | Device | NexSite HD Patients |
Primary outcome
Number of participants with Catheter-Related Blood Stream Infection (CRBSI)(bacteremia/fungemia) as an adverse event.
Time frame: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with a confirmed CRBSI for the duration of catheter use or to 180 days post device placement (whichever occurs first)
6 secondary outcomes
Number of participants with adverse events associated with device placement and use.
Time frame: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with unhealed catheter exit sites
Time frame: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with tunnel infection as an adverse event
Time frame: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with exit site infection as an adverse event
Time frame: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with Pneumothorax, haemothorax, arrhythmia, air embolism or arterial perforation as an adverse event.
Time frame: 1 day of device placement
Number of participants with Catheter dislodgement, Catheter tip dislodgement and catheter thrombosis as an adverse event.
Time frame: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Individual participant dataSharing planned: No
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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 G Hoggard, MD principal investigator
Capital Nephrology Associates
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NexSite HD Patients in people with End Stage Renal Disease, run by Marvao Medical at 6 sites 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 6 inclusion and 18 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 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with Catheter-Related Blood Stream Infection (CRBSI)(bacteremia/fungemia) as an adverse event. (time frame: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2018.