The purpose of this clinical trial is to compare the longevity of two dialysis catheters.
This study is a multi-center, randomized, prospective, open-label, clinical study comparing a conventional split-tip catheter and a symmetric tip catheter in subjects undergoing hemodialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
599
Dialysis catheter
Dialysis Catheter
Nephrology Associates, P.C.
Birmingham, Alabama, United States
Southwest Kidney Institute
Phoenix, Arizona, United States
Tufts Medical Center
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Time frame: 30 days
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Time frame: 60 days
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Time frame: 245 days
Inadequate Flow Rates Requiring Surgical/Radiological Intervention
Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'.
Time frame: 35 weeks
Average Number of Line Reversals Per Subject
Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments
Time frame: 35 Weeks
Frequency of Clinician Interventions for Catheter Malfunction and Infection
Average number of times clinician intervention was required for either catheter malfunction or infection
Time frame: 35 Weeks
Primary Failure Rate
The percentage of catheters unable to deliver adequate blood flow of at least 300 mL/min for at least 50% of measurements during the first attempted dialysis session.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
SUNY Stony Brook Medical Center
Stony Brook, New York, United States
Eastern Nephrology Associates
Greenville, North Carolina, United States
Eastern Nephrology Associates
New Bern, North Carolina, United States
Boice-Willis Clinic
Rocky Mount, North Carolina, United States
Dialysis Access Group of Wake Forest University, LLC
Winston-Salem, North Carolina, United States
Toledo Hospital
Toledo, Ohio, United States
...and 4 more locations
Time frame: First dialysis session with study catheter
Reliability of the Catheter
Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.
Time frame: 35 Weeks