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

End Stage Renal Disease on Dialysis (Diagnosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03523260
• Other study ID #: IRB-130430002
• Status: Withdrawn
• Phase: N/A
• Start date: August 27, 2013
• Est. completion date: January 22, 2020

Study information

• Verified date: May 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis (Diagnosis)
• Kidney Failure, Chronic

Intervention

Device:
• Tunneled dialysis catheter placement.
Placement of high-flow tunneled catheter for hemodialysis

Locations

Country	Name	City	State
United States	University of Akabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	1 month complication rate of left internal jugular vein dialysis catheters	1 month
Secondary	Catheter dysfunction	1 month complication rate of left internal jugular vein dialysis catheters	1 months
Secondary	Catheter dysfunction	3 months complication rate of left internal jugular vein dialysis catheters	3 months
Secondary	Catheter dysfunction	6 months complication rate of left internal jugular vein dialysis catheters	6 months
Secondary	Complication rate	3 months complication rate of left internal jugular vein dialysis catheters	3 months
Secondary	Complication rate	6 months complication rate of left internal jugular vein dialysis catheters	6 months