Chronic Renal Insufficiency, Renal Failure Chronic Requiring Hemodialysis
Conditions
Brief summary
Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled dialysis catheters.
Detailed description
The VectorFlow tunneled dialysis catheter is a novel symmetrical tip design tunneled dialysis catheter which in pre-clinical testing and retrospective review has improved flow and patency compared to other dialysis catheter designs. This study will compare 90 day patency rates of newly inserted VF catheters to the Palindrome catheter both of which are FDA approved devices and will inserted as standard of care. The Palindrome catheter has been selected as the comparison device because it is also a symmetrical tip catheter design and prior studies by the manufacturer of this device suggests it has a lower occlusion rate and better flow compared to other catheter designs.
Interventions
DEVICEVectorFlow TDC
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.
DEVICEPalindrome 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.
Sponsors
Teleflex
Arrow International
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency - Intervention-free Interval (Measured in Weeks) | 30, 60 and 90 days | The primary study endpoint will be primary patency at 90 days following catheter insertion. Primary patency is defined as an HD catheter which provides adequate hemodialysis (flow \>300mL/min) without need for additional interventions (ie TPA infusions or catheter exchange) to maintain flow or correct device failure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Palindrome 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. | 50 |
| VectorFlow TDC 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. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Insertion of immediately puncturable graft. | 1 | 1 |
Baseline characteristics
| Characteristic | VectorFlow TDC | Total | Palindrome TDC |
|---|---|---|---|
| Age, Continuous | 59 years | 58 years | 57 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 100 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 50 Participants | 100 Participants | 50 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 26 Participants | 46 Participants | 20 Participants |
| Sex: Female, Male Male | 24 Participants | 54 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Primary Patency - Intervention-free Interval (Measured in Weeks)
The primary study endpoint will be primary patency at 90 days following catheter insertion. Primary patency is defined as an HD catheter which provides adequate hemodialysis (flow \>300mL/min) without need for additional interventions (ie TPA infusions or catheter exchange) to maintain flow or correct device failure.
Time frame: 30, 60 and 90 days
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Palindrome TDC | Primary Patency - Intervention-free Interval (Measured in Weeks) | 30 Days | 89.1 percentage of primary patency | Standard Error 6.2 |
| Palindrome TDC | Primary Patency - Intervention-free Interval (Measured in Weeks) | 60 Days | 79.4 percentage of primary patency | Standard Error 10 |
| Palindrome TDC | Primary Patency - Intervention-free Interval (Measured in Weeks) | 90 days | 71.5 percentage of primary patency | Standard Error 12.6 |
| VectorFlow TDC | Primary Patency - Intervention-free Interval (Measured in Weeks) | 30 Days | 95.5 percentage of primary patency | Standard Error 3.3 |
| VectorFlow TDC | Primary Patency - Intervention-free Interval (Measured in Weeks) | 60 Days | 87.2 percentage of primary patency | Standard Error 7.3 |
| VectorFlow TDC | Primary Patency - Intervention-free Interval (Measured in Weeks) | 90 days | 80.6 percentage of primary patency | Standard Error 9.8 |