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

NCT02453646 | Completed DMC

• 1 other identifier: TR 0147
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of participants with adverse events associated with device placement and use.

  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

  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

  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

  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.

  1 day of device placement

Study Arms (1)

NexSite HD Patients

EXPERIMENTAL

NexSite HD patient catheter device placement

Device: NexSite HD Patients

Interventions

NexSite HD Patients DEVICE

Measurement of CRBSI rate and other device related adverse events in patients with NexSite HD Catheter.

NexSite HD Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Marvao Medical: lead

Study Sites (6)

Eastern Nephrology Associates

Greenville, North Carolina, 27834, United States

Location

Eastern Nephology Associates

New Bern, North Carolina, 28542, United States

Location

Capital Nephrology Associates

Raleigh, North Carolina, 27610, United States

Location

South Carolina Nephrology and Hypertension Center Inc

Orangeburg, South Carolina, 29118, United States

Location

Lubbock Vascular Access Centre

Lubbock, Texas, 79416, United States

Location

Renal Associates

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey G Hoggard, MD

  Capital Nephrology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 25, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: July 1, 2018
• Last Updated: October 1, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)