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

Completed · Not applicable

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT02453646

Run by

Marvao Medical

People needed

120

Starts

2015-04-01

Expected to finish

2018-07-01

Last updated by the study team

2018-10-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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