CompletedNot Applicable

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

United States120 participantsStarted 2015-04

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Number of participants with Catheter-Related Blood Stream Infection (CRBSI)(bacteremia/fungemia) as an adverse event.

Timeframe: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)

Trial details

NCT IDNCT02453646

SponsorMarvao Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09

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