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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
120
Measurement of CRBSI rate and other device related adverse events in patients with NexSite HD Catheter.
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
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)
Time frame: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
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Lubbock Vascular Access Centre
Lubbock, Texas, United States
Renal Associates
San Antonio, Texas, United States
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.
Time frame: 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).
Time frame: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)