Analysis of CRBSI Rates in Patients With a NexSite™ HD (Hemodialysis) Catheter

September 28, 2018 updated by: Marvao Medical

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Eastern Nephrology Associates
      • New Bern, North Carolina, United States, 28542
        • Eastern Nephology Associates
      • Raleigh, North Carolina, United States, 27610
        • Capital Nephrology Associates
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • South Carolina Nephrology and Hypertension Center Inc
    • Texas
      • Lubbock, Texas, United States, 79416
        • Lubbock Vascular Access Centre
      • San Antonio, Texas, United States, 78215
        • Renal Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The patient shall be 18 - 80 years old.
  2. The patient requires the placement of a long term tunnelled HD catheter for administration of hemodialysis.
  3. The patient has anticipated survival in excess of 90 days from the anticipated date of catheter placement.
  4. 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.
  5. The patient receives the catheter via the internal jugular or subclavian vein.
  6. All female patients of child bearing potential must complete a negative pregnancy test and will confirm that they are not breastfeeding.

Exclusion Criteria:

  1. 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.
  2. The patient has a confirmed or suspected infection, bacteraemia or septicaemia.
  3. 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.
  4. The patient is known or suspected to have allergies to the materials used in the construction of the device.
  5. The patient has previously suffered from coagulation issues or has had vascular surgery at the proposed placement site.
  6. The patient has received radiation treatment at the proposed catheter placement site.
  7. The patient has severe chronic obstructive lung disease.
  8. 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.
  9. 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)
  10. The patient has another indwelling catheter.
  11. The patient has non-healing diabetic foot ulcers.
  12. The patient did not give informed consent.
  13. The patient would be unavailable for follow-up.
  14. The patient is a permanent nursing home resident.
  15. The proposed access site is not the internal jugular or subclavian vein.
  16. The patient is scheduled to undergo an elective surgical procedure (other than a procedure to create a graft or fistula) within the study timeframe.
  17. Any other condition that the Investigator believes should exclude the patient from the study.
  18. The patient does not have English or Spanish as their first language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NexSite HD Patients
NexSite HD patient catheter device placement
Device: NexSite HD Patients
Measurement of CRBSI rate and other device related adverse events in patients with NexSite HD Catheter.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 adverse events associated with device placement and for the duration of catheter use or to 180 days post device placement.
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 unhealed exit sites for the duration of catheter use or to 180 days post device placement (whichever occurs first)
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 a tunnel infection for the duration of catheter use or to 180 days post device placement (whichever occurs first)
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 a exit site infection for the duration of catheter use or to 180 days post device placement (whichever occurs first)
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 non-infectious catheter complications within one day of placement.
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)
Number of participants with late non infectious complications for the duration of catheter use or to 180 days post device placement (whichever occurs first).
Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marvao Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey G Hoggard, MD, Capital Nephrology Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TR 0147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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