End Stage Renal Disease Clinical Trial
Official title:
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.
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
;
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