NCT03523260

Comparison of High-Flow Hemodialysis Catheters Placed From the Left Internal Jugular Vein(R12-022)

High-Flow Hemodialysis Catheters Placed Through the Left Internal Jugular Approach (R12-022)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease on Dialysis (Diagnosis)

Interventions

Type	Name	Description
DEVICE	Tunneled dialysis catheter placement.	Placement of high-flow tunneled catheter for hemodialysis

Timeline

• Start date: 2013-08-27
• Primary completion: 2020-01-22
• Completion: 2020-01-22
• First posted: 2018-05-14
• Last updated: 2021-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study