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

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: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: NexSite HD Patients

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: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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)	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)	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.	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).	Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)

Collaborators and Investigators

• Sponsor: Marvao Medical
• Investigators: Principal Investigator: Jeffrey G Hoggard, MD, Capital Nephrology Associates

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): October 1, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: TR 0147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO