Chronic Kidney Disease
Conditions
Keywords
bioflo, Duramax catheter, dialysis
Brief summary
Numerous catheter designs have been studied to increase efficacy and minimize complications of catheter hemodialysis. Major complications of catheters include thrombosis, central venous stenosis, infection, and dialysis inadequacy. Thrombosis must be avoided if possible because using too many catheters may exhaust all of the catheter insertion sites on the body, as well as increase the risk of infection. This prospective study compares the complications and general outcomes of patients who receive hemodialysis using the mainstream Palindrome catheter versus the newer BioFlo DuraMax catheter. This study will examine outcomes of patients who receive hemodialysis using either the Palindrome catheter or the BioFlo catheter. Patients will be observed and outcomes will be recorded for three to six months. Outcomes will be analyzed and compared to draw conclusions on which catheter produces less catheter thrombosis.
Interventions
DEVICEBioflo Dialysis Catheter
The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract.
DEVICEPalindrome Dialysis Catheter
The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract.
Sponsors
Angiodynamics, Inc.
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females 18 - 65 years of age; 2. First de novo dialysis catheter placement or second catheter exchange, no more than 3 replacements on a same site 3. Requiring at least 3 months dialysis catheter usage 4. No clinical or radiographic evidence of superior vena cava (SVC) narrowing 5. Patent right internal or external jugular vein 6. Willing to provide the dialysis center information for F/U 7. No known diagnosis of hypercoagulopathy
Exclusion criteria
1. Short term catheter usage plan (\< 1 months) 2. No right jugular venous access 3. Catheter use for bone marrow transplant or plasmapheresis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. | 1 month | A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. | 3 months | A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups in three month follow-up |
| Cost Analysis | 3 months | To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange. |
Countries
United States
Participant flow
Recruitment details
Recruitment period = 01/2017 to 12/2018 Location = UCLA Santa Monica Hospital
Pre-assignment details
No significant events occurred in this study prior to assignment to a group
Participants by arm
| Arm | Count |
|---|---|
| Bioflo Goup This group will have dialysis using the Bioflo catheter.
Bioflo Dialysis Catheter: The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract. | 10 |
| Palindrome Group This group will have dialysis using the Palindrome catheter.
Palindrome Dialysis Catheter: The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract. | 22 |
| Total | 32 |
Baseline characteristics
| Characteristic | Palindrome Group | Total | Bioflo Goup |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 14 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 18 Participants | 8 Participants |
| Age, Continuous | 61.2 years STANDARD_DEVIATION 18.6 | 57.8 years STANDARD_DEVIATION 18 | 50.2 years STANDARD_DEVIATION 14.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 22 participants | 32 participants | 10 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 3 Participants |
| Sex: Female, Male Male | 15 Participants | 22 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 3 / 22 |
| other Total, other adverse events | 0 / 10 | 0 / 22 |
| serious Total, serious adverse events | 0 / 10 | 0 / 22 |
Outcome results
Primary
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioflo Goup | Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. | 4.3 catheter thrombosis per month | Standard Error 0.56 |
| Palindrome Group | Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. | 7.27 catheter thrombosis per month | Standard Error 0.49 |
Secondary
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups in three month follow-up
Time frame: 3 months
Population: Two patients in the Palindrome group were not included in this outcome measure analysis. One patient received the kidney transplant during the 3 month follow-up and the second patient died during the 3 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioflo Goup | Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. | 8.6 catheter thrombosis per 3 months | Standard Error 0.81 |
| Palindrome Group | Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters. | 12.4 catheter thrombosis per 3 months | Standard Error 1.07 |
Secondary
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.
Time frame: 6 months
Population: 6 month data were not collected due to a stopping rule invoked after the 3-month data were analyzed
Secondary
Cost Analysis
To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange.
Time frame: 3 months
Population: Two patients in the Palindrome group were not included in this outcome measure analysis. One patient received the kidney transplant during the 3 month follow-up and the second patient died during the 3 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioflo Goup | Cost Analysis | 60200 US Dollar | Standard Error 5638.75 |
| Palindrome Group | Cost Analysis | 78909 US Dollar | Standard Error 8716.53 |