VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC (TDC)
Renal Failure Chronic Requiring Hemodialysis, Chronic Renal Insufficiency
About this trial
This is an interventional treatment trial for Renal Failure Chronic Requiring Hemodialysis
Eligibility Criteria
Inclusion Criteria:
- End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter
- Age >18, Age <80
- Capable of giving informed consent
Exclusion Criteria:
- Coagulopathy defined as international normalized ration (INR) >2 which cannot be corrected with fresh frozen plasma
- Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion
- Active skin infections at site of TDC insertion
- Presence of bacteremia or infected AVG/AVF within 7 days prior to enrollment
- Neutropenia defined as absolute neutrophil count less then 1,700/microliter
- Known central venous stenosis
- Occlusion of bilateral external and internal jugular veins or bilateral brachiocephalic veins or stenosis of the superior vena cava
- Functioning surgical HD access (ie AVG/AVF) or AVG/AVF which is expected to be functional within 90 days of enrollment
- Inability to provide informed consent
- Pregnant or nursing women
- In the event a physician does not feel that either catheter would be appropriate for a subject, the subject will not be eligible to participate
Sites / Locations
- Hospital of the Unviersity of Pennsylvania
- Penn Presbyterian Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Palindrome TDC
VectorFlow TDC
TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.
TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.