Clinical trial NCT03523260: Comparison of High-Flow Hemodialysis Catheters Placed From the Left Internal Jugular Vein(R12-022)
Official title: High-Flow Hemodialysis Catheters Placed Through the Left Internal Jugular Approach (R12-022)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: End Stage Renal Disease on Dialysis (Diagnosis)
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication rate
timeFrame: 1 month
Secondary outcomes:
measure: Catheter dysfunction
timeFrame: 1 months
measure: Catheter dysfunction
timeFrame: 3 months
measure: Catheter dysfunction
timeFrame: 6 months
measure: Complication rate
timeFrame: 3 months
measure: Complication rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Akabama at Birmingham
state: Alabama
Study officials:
References: