End Stage Renal Disease on Dialysis (Diagnosis)
Conditions
Brief summary
The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. This study will review and compare the complication rate and function of the three catheter designs.
Detailed description
The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. Participants will be randomized to receive a split-tip, step-tip or symmetric tip catheter in a 1:1:1 ratio. All participants will be followed per their referring physician's standard of care. Information regarding any patient complications will be obtained from Dr. Allon's dialysis patient database (Vascular Access in Hemodialysis Patients, IRB # X980813005). This study will review and compare the complication rate and function of the three catheter designs. There are no studies to our knowledge that compared catheter designs placed specifically via the left internal jugular vein. The investigators hypothesize that because the left internal jugular vein is anatomically more complex than the right one, tunneled dialysis catheters with split-tip design may perform sub-optimally, compared to step-tip and symmetric tip designs, when placed via the left internal jugular vein. If this hypothesis is true, the results of the study may influence future clinical practice and reduce the rates of replacement of catheters placed through the left internal jugular vein, resulting in better patient care and significant cost-savings.
Interventions
DEVICETunneled dialysis catheter placement.
Placement of high-flow tunneled catheter for hemodialysis
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing and able to provide a written informed consent 2. 19 years or older 3. Hemodialysis patient needing high-flow polyurethane tunneled dialysis catheter placement via the left internal jugular vein. 4. Patent left internal jugular vein. 5. Able to read and understand English.
Exclusion criteria
1. Previous enrollment in this trial 2. Patients unable or unwilling to provide informed consent 3. Prisoners or incarcerated individuals 4. Women who are pregnant 5. Patients in whom the left internal jugular vein is occluded or catheter placement is otherwise contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | 1 month | 1 month complication rate of left internal jugular vein dialysis catheters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheter dysfunction | 1 months | 1 month complication rate of left internal jugular vein dialysis catheters |
| Complication rate | 3 months | 3 months complication rate of left internal jugular vein dialysis catheters |
Countries
United States
Outcome results
None listed