Chronic Kidney Failure
Conditions
Keywords
Dialyzer
Brief summary
The purpose of this study is to collect information on the ease of use and thrombogenicity of the Polyflux HD-C4 Big and Fresenius Optiflux 180NR or 200NR dialyzers under conditions of routine clinical use for hemodialysis.
Detailed description
This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is aimed at obtaining feedback from the nursing and technical staff regarding the use and thrombogenicity of the Polyflux HD-C4 Big, and Fresenius Optiflux 180NR or 200NR dialyzers. The dialysis nursing staff will complete ease of use and thrombogenicity assessments following routine dialysis therapy. Any adverse events will be tracked for the study patients.
Interventions
None listed
Sponsors
Advanced Dialysis Center of Potomac
Advanced Dialysis Center of Easton
Gambro Renal Products, Inc.
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hemodialysis patients 18 years of age or older
Exclusion criteria
* n/a
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use: Priming Blood Side | Priming at each treatment | For every study treatment/dialyzer, the nursing staff rated the ease of priming blood side as follows: Very Easy:Air is easily removed without knocking or clamping procedures. Acceptable:Knocking and/or clamping required for efficient air removal. Difficult:Knocking and/or clamping and additional volume of saline or extended recirculation needed to remove air. Very Difficult:Air could not be removed. |
| Ease of Use: Priming Dialysate Side | Priming at each treatment | For every study treatment/dialyzer, the nursing staff rated the ease of priming dialysate side as follows: Dialysate Side at 500 ml Priming Volume (check one): Perfect: No air visible. Acceptable: Some air visible, but considered insignificant. Not Acceptable: Additional actions needed to sufficiently remove air. |
| Dialyzer Assessment: Fiber Condition | Each treatment: assessment of the condition of the dialyzer fibers after rinse-back | For every study treatment/dialyzer, the nursing staff rated the condition of the dialyzer fibers after rinse-back as follows: Very Good:All fibers appear white. Good:Few fibers (less than 10) appear PINK / RED. (check one) Poor:Several fibers (more than 10) appear PINK / RED. (check one) Very Poor:Most fibers (more than 75%) appear PINK / RED. (check one) |
| Dialyzer Assessment: Arterial Header Condition | Each treatment: assessment of the condition of the arterial header after rinse-back | For every study treatment/dialyzer, the nursing staff rated the condition of the arterial header after rinse-back as follows: Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots. |
| Dialyzer Assessment: Venous Header Condition | Each treatment: the assessment of the condition of the venous header after rinse-back | For every study treatment/dialyzer, the nursing staff rated the condition of the venous header after rinse-back as follows: Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hemodialysis Patients Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Hemodialysis Patients |
|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 11.1 |
| Height | 65.6 inches STANDARD_DEVIATION 4.3 |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Dialyzer Assessment: Arterial Header Condition
For every study treatment/dialyzer, the nursing staff rated the condition of the arterial header after rinse-back as follows: Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots.
Time frame: Each treatment: assessment of the condition of the arterial header after rinse-back
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Revaclear MAX | Dialyzer Assessment: Arterial Header Condition | Good | 49 Number of Dialyzers |
| Revaclear MAX | Dialyzer Assessment: Arterial Header Condition | Very Poor | 1 Number of Dialyzers |
| Revaclear MAX | Dialyzer Assessment: Arterial Header Condition | Very Good | 155 Number of Dialyzers |
| Revaclear MAX | Dialyzer Assessment: Arterial Header Condition | Poor | 13 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Arterial Header Condition | Poor | 26 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Arterial Header Condition | Very Good | 0 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Arterial Header Condition | Very Poor | 3 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Arterial Header Condition | Good | 66 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Arterial Header Condition | Very Poor | 2 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Arterial Header Condition | Good | 64 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Arterial Header Condition | Very Good | 0 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Arterial Header Condition | Poor | 30 Number of Dialyzers |
Primary
Dialyzer Assessment: Fiber Condition
For every study treatment/dialyzer, the nursing staff rated the condition of the dialyzer fibers after rinse-back as follows: Very Good:All fibers appear white. Good:Few fibers (less than 10) appear PINK / RED. (check one) Poor:Several fibers (more than 10) appear PINK / RED. (check one) Very Poor:Most fibers (more than 75%) appear PINK / RED. (check one)
Time frame: Each treatment: assessment of the condition of the dialyzer fibers after rinse-back
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Revaclear MAX | Dialyzer Assessment: Fiber Condition | Very Good | 126 Number of Dialyzers |
| Revaclear MAX | Dialyzer Assessment: Fiber Condition | Good | 75 Number of Dialyzers |
| Revaclear MAX | Dialyzer Assessment: Fiber Condition | Poor | 12 Number of Dialyzers |
| Revaclear MAX | Dialyzer Assessment: Fiber Condition | Very Poor | 5 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Fiber Condition | Very Poor | 11 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Fiber Condition | Very Good | 23 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Fiber Condition | Poor | 17 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Fiber Condition | Good | 44 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Fiber Condition | Very Poor | 7 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Fiber Condition | Good | 45 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Fiber Condition | Poor | 30 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Fiber Condition | Very Good | 15 Number of Dialyzers |
Primary
Dialyzer Assessment: Venous Header Condition
For every study treatment/dialyzer, the nursing staff rated the condition of the venous header after rinse-back as follows: Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots.
Time frame: Each treatment: the assessment of the condition of the venous header after rinse-back
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Revaclear MAX | Dialyzer Assessment: Venous Header Condition | Poor | 7 Number of Dialyzers |
| Revaclear MAX | Dialyzer Assessment: Venous Header Condition | Very Poor | 5 Number of Dialyzers |
| Revaclear MAX | Dialyzer Assessment: Venous Header Condition | Good | 140 Number of Dialyzers |
| Revaclear MAX | Dialyzer Assessment: Venous Header Condition | Very Good | 65 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Venous Header Condition | Very Good | 0 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Venous Header Condition | Good | 31 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Venous Header Condition | Very Poor | 11 Number of Dialyzers |
| Optiflux F180NR | Dialyzer Assessment: Venous Header Condition | Poor | 52 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Venous Header Condition | Very Poor | 5 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Venous Header Condition | Very Good | 0 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Venous Header Condition | Good | 35 Number of Dialyzers |
| Optiflux F200NR | Dialyzer Assessment: Venous Header Condition | Poor | 57 Number of Dialyzers |
Primary
Ease of Use: Priming Blood Side
For every study treatment/dialyzer, the nursing staff rated the ease of priming blood side as follows: Very Easy:Air is easily removed without knocking or clamping procedures. Acceptable:Knocking and/or clamping required for efficient air removal. Difficult:Knocking and/or clamping and additional volume of saline or extended recirculation needed to remove air. Very Difficult:Air could not be removed.
Time frame: Priming at each treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Revaclear MAX | Ease of Use: Priming Blood Side | Very Easy | 139 Number of Dialyzers |
| Revaclear MAX | Ease of Use: Priming Blood Side | Acceptable | 80 Number of Dialyzers |
| Optiflux F180NR | Ease of Use: Priming Blood Side | Very Easy | 13 Number of Dialyzers |
| Optiflux F180NR | Ease of Use: Priming Blood Side | Acceptable | 82 Number of Dialyzers |
| Optiflux F200NR | Ease of Use: Priming Blood Side | Very Easy | 13 Number of Dialyzers |
| Optiflux F200NR | Ease of Use: Priming Blood Side | Acceptable | 84 Number of Dialyzers |
Primary
Ease of Use: Priming Dialysate Side
For every study treatment/dialyzer, the nursing staff rated the ease of priming dialysate side as follows: Dialysate Side at 500 ml Priming Volume (check one): Perfect: No air visible. Acceptable: Some air visible, but considered insignificant. Not Acceptable: Additional actions needed to sufficiently remove air.
Time frame: Priming at each treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Revaclear MAX | Ease of Use: Priming Dialysate Side | Perfect | 131 Number of Dialyzers |
| Revaclear MAX | Ease of Use: Priming Dialysate Side | Acceptable | 89 Number of Dialyzers |
| Optiflux F180NR | Ease of Use: Priming Dialysate Side | Perfect | 4 Number of Dialyzers |
| Optiflux F180NR | Ease of Use: Priming Dialysate Side | Acceptable | 91 Number of Dialyzers |
| Optiflux F200NR | Ease of Use: Priming Dialysate Side | Perfect | 2 Number of Dialyzers |
| Optiflux F200NR | Ease of Use: Priming Dialysate Side | Acceptable | 95 Number of Dialyzers |