Trial Outcomes & Findings for A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients (NCT NCT02433210)
NCT ID: NCT02433210
Last Updated: 2022-08-05
Results Overview
Clearances of small, middle and large molecular weight solutes will be measured at 60 minute time point utilizing urea, creatinine, beta 2 microglobulin, phosphate and myoglobin. Dialyzer clearance is calculated as follows: 60 minute clearance:(((\[S\]60'Art - \[S\]60'Ven) / \[S\]60'Art) \* Qb) where \[S\] = solute concentration; Qb = blood flow rate. S
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
During each of the three weekly dialysis sessions measurements of urea were made at the 60 minute time point for each patient in the study. At the end of the study all measurements were summed for each of the three dialyzers.
Results posted on
2022-08-05
Participant Flow
Patients were pre-screened to determine if met inclusion/exclusion criteria by the study coordinator. If they met the criteria the primary investigator met with them explained the project and if interested he then consented them. Once consented the patient started the study on the following Monday.
There were no significant events. We didn't lose any consented patients prior to starting the study. There was no special preparation prior to start of study other than inclusion/exclusion criteria which took place prior to consent.
Participant milestones
| Measure |
Experimental: ELISIO, Then Revaclear, Then Optiflux
This group will start week one with the ELISIO dialyzer, followed by the Revaclear dialyzer in week two and in the third finish with the Optiflux dialyzer. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen.
|
Experimental: Revaclear, Then Optiflux, Then ELISIO
This group will start week one with the Revaclear dialyzer, followed by the Optiflux dialyzer in week two and finish with the ELISIO dialyzer in week three. . Each patient will undergo three successive hemodialysis sessions during each week following their established regimen.
|
Experimental: Optiflux, Then ELISIO, Then Revaclear
This group will start with the Optiflux dialyzer in week one, followed by the ELISIO dialyzer in week two and finish with the Revaclear dialyzer in week three. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Experimental: ELISIO, Then Revaclear, Then Optiflux
This group will start week one with the ELISIO dialyzer, followed by the Revaclear dialyzer in week two and in the third finish with the Optiflux dialyzer. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen.
|
Experimental: Revaclear, Then Optiflux, Then ELISIO
This group will start week one with the Revaclear dialyzer, followed by the Optiflux dialyzer in week two and finish with the ELISIO dialyzer in week three. . Each patient will undergo three successive hemodialysis sessions during each week following their established regimen.
|
Experimental: Optiflux, Then ELISIO, Then Revaclear
This group will start with the Optiflux dialyzer in week one, followed by the ELISIO dialyzer in week two and finish with the Revaclear dialyzer in week three. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen.
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|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
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Baseline Characteristics
A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Experimental: ELISIO, Then Revaclear, Then Optiflux
n=4 Participants
This group will start week one with the ELISIO dialyzer, followed by the Revaclear dialyzer in week two and in the third finish with the Optiflux dialyzer. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen.
|
Experimental: Revaclear, Then Optiflux, Then ELISIO
n=3 Participants
This group will start week one with the Revaclear dialyzer, followed by the Optiflux dialyzer in week two and finish with the ELISIO dialyzer in week three. . Each patient will undergo three successive hemodialysis sessions during each week following their established regimen.
|
Experimental: Optiflux, Then ELISIO, Then Revaclear
n=3 Participants
This group will start with the Optiflux dialyzer in week one, followed by the ELISIO dialyzer in week two and finish with the Revaclear dialyzer in week three. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 14.8 • n=39 Participants
|
53.6 years
STANDARD_DEVIATION 3.9 • n=41 Participants
|
56.3 years
STANDARD_DEVIATION 7.8 • n=35 Participants
|
57.2 years
STANDARD_DEVIATION 10.91 • n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=39 Participants
|
3 participants
n=41 Participants
|
3 participants
n=35 Participants
|
10 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: During each of the three weekly dialysis sessions measurements of urea were made at the 60 minute time point for each patient in the study. At the end of the study all measurements were summed for each of the three dialyzers.Clearances of small, middle and large molecular weight solutes will be measured at 60 minute time point utilizing urea, creatinine, beta 2 microglobulin, phosphate and myoglobin. Dialyzer clearance is calculated as follows: 60 minute clearance:(((\[S\]60'Art - \[S\]60'Ven) / \[S\]60'Art) \* Qb) where \[S\] = solute concentration; Qb = blood flow rate. S
Outcome measures
| Measure |
BUN Clearance Optiflux
n=10 Participants
Solute clearance at 60 minutes for urea
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Revaclear
n=10 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Elisio
n=10 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance Optiflux
n=10 Participants
Solute clearance at 60 minutes for creatinine.
|
Creatinine Clearance Revaclear
n=10 Participants
Solute clearance at 60 minutes for creatinine.
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance ELISIO
n=10 Participants
Solute clearance at 60 minutes for creatinine,
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Phosphate Clearance Optiflux
n=10 Participants
Phosphate clearance at 60 minutes
|
Phosphate Clearance Revaclear
n=10 Participants
Phosphate Clearance at 60 minutes.
|
Phosphate Clearance Elisio
n=10 Participants
Phosphate Clearance at 60 minutes.
|
Beta 2 Microglobulin Revaclear
n=10 Participants
Beta 2 microglobulin clearance at 60 minutes
|
Beta 2 Microglobulin Optiflux
n=10 Participants
Beta 2 microglobulin clearance at 60 minutes.
|
Beta 2 Microglobulin ELISIO
n=10 Participants
Beta 2 Microglobulin clearance at 60 minutes.
|
Myoglobin Clearance Optiflux
n=10 Participants
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance Revaclear
n=10 Participants
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance ELISIO
n=10 Participants
Myoglobin clearance at 60 minutes.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clearance and Solute Removal Characteristics of Dialyzers
Session 2
|
336.2 milliliters per minute (ml/min)
Standard Deviation 57.4
|
352.8 milliliters per minute (ml/min)
Standard Deviation 40.1
|
356.3 milliliters per minute (ml/min)
Standard Deviation 44.1
|
256.7 milliliters per minute (ml/min)
Standard Deviation 78.6
|
297.6 milliliters per minute (ml/min)
Standard Deviation 39.9
|
293.4 milliliters per minute (ml/min)
Standard Deviation 37
|
306.4 milliliters per minute (ml/min)
Standard Deviation 43
|
324.7 milliliters per minute (ml/min)
Standard Deviation 45.3
|
277 milliliters per minute (ml/min)
Standard Deviation 90.3
|
144 milliliters per minute (ml/min)
Standard Deviation 26.8
|
63 milliliters per minute (ml/min)
Standard Deviation 49.7
|
165.7 milliliters per minute (ml/min)
Standard Deviation 51.5
|
-2.6 milliliters per minute (ml/min)
Standard Deviation 26.4
|
32.6 milliliters per minute (ml/min)
Standard Deviation 53.5
|
19.1 milliliters per minute (ml/min)
Standard Deviation 64.3
|
|
Clearance and Solute Removal Characteristics of Dialyzers
Session 1
|
354.1 milliliters per minute (ml/min)
Standard Deviation 48
|
340.4 milliliters per minute (ml/min)
Standard Deviation 72.5
|
361.8 milliliters per minute (ml/min)
Standard Deviation 51
|
271.8 milliliters per minute (ml/min)
Standard Deviation 65.2
|
295.9 milliliters per minute (ml/min)
Standard Deviation 53.7
|
298.4 milliliters per minute (ml/min)
Standard Deviation 49.3
|
309.8 milliliters per minute (ml/min)
Standard Deviation 71
|
324.8 milliliters per minute (ml/min)
Standard Deviation 60.5
|
333.1 milliliters per minute (ml/min)
Standard Deviation 48.3
|
137.6 milliliters per minute (ml/min)
Standard Deviation 38.7
|
57.2 milliliters per minute (ml/min)
Standard Deviation 41.5
|
169.1 milliliters per minute (ml/min)
Standard Deviation 59.6
|
-7.1 milliliters per minute (ml/min)
Standard Deviation 29
|
24.5 milliliters per minute (ml/min)
Standard Deviation 57.6
|
33.4 milliliters per minute (ml/min)
Standard Deviation 47.4
|
|
Clearance and Solute Removal Characteristics of Dialyzers
Session 3
|
331.9 milliliters per minute (ml/min)
Standard Deviation 62.9
|
318.8 milliliters per minute (ml/min)
Standard Deviation 69.4
|
355.7 milliliters per minute (ml/min)
Standard Deviation 58.3
|
277.8 milliliters per minute (ml/min)
Standard Deviation 59.2
|
275.5 milliliters per minute (ml/min)
Standard Deviation 39.2
|
296.6 milliliters per minute (ml/min)
Standard Deviation 33.3
|
296.6 milliliters per minute (ml/min)
Standard Deviation 69.7
|
276.6 milliliters per minute (ml/min)
Standard Deviation 100.9
|
330.4 milliliters per minute (ml/min)
Standard Deviation 47.9
|
149.6 milliliters per minute (ml/min)
Standard Deviation 28
|
61.4 milliliters per minute (ml/min)
Standard Deviation 24.7
|
136.4 milliliters per minute (ml/min)
Standard Deviation 90.3
|
-8.6 milliliters per minute (ml/min)
Standard Deviation 12.6
|
62.1 milliliters per minute (ml/min)
Standard Deviation 108.2
|
45.5 milliliters per minute (ml/min)
Standard Deviation 40
|
PRIMARY outcome
Timeframe: Once a week during the second of the three weekly sessions specimens will be taken at time points 0, 15, 30, 60 and 240 minutes. Measurements, all patients, were summed for each dialyzer type by time period.The molecules monitored will be C5a, thrombin/anti-thrombin complex and a complete blood count with platelets.
Outcome measures
| Measure |
BUN Clearance Optiflux
n=10 Participants
Solute clearance at 60 minutes for urea
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Revaclear
n=8 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Elisio
n=10 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance Optiflux
n=10 Participants
Solute clearance at 60 minutes for creatinine.
|
Creatinine Clearance Revaclear
n=8 Participants
Solute clearance at 60 minutes for creatinine.
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance ELISIO
n=10 Participants
Solute clearance at 60 minutes for creatinine,
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Phosphate Clearance Optiflux
n=9 Participants
Phosphate clearance at 60 minutes
|
Phosphate Clearance Revaclear
n=8 Participants
Phosphate Clearance at 60 minutes.
|
Phosphate Clearance Elisio
n=10 Participants
Phosphate Clearance at 60 minutes.
|
Beta 2 Microglobulin Revaclear
n=10 Participants
Beta 2 microglobulin clearance at 60 minutes
|
Beta 2 Microglobulin Optiflux
n=8 Participants
Beta 2 microglobulin clearance at 60 minutes.
|
Beta 2 Microglobulin ELISIO
n=10 Participants
Beta 2 Microglobulin clearance at 60 minutes.
|
Myoglobin Clearance Optiflux
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance Revaclear
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance ELISIO
Myoglobin clearance at 60 minutes.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers
|
8.5 Percent change from baseline
Standard Deviation 28.0
|
-5.1 Percent change from baseline
Standard Deviation 26.8
|
-4.5 Percent change from baseline
Standard Deviation 15.4
|
11.2 Percent change from baseline
Standard Deviation 17.8
|
7.5 Percent change from baseline
Standard Deviation 25.3
|
-1.1 Percent change from baseline
Standard Deviation 19.6
|
-17.7 Percent change from baseline
Standard Deviation 22.8
|
-9.8 Percent change from baseline
Standard Deviation 22.7
|
-6.1 Percent change from baseline
Standard Deviation 35.4
|
15.9 Percent change from baseline
Standard Deviation 15.6
|
-6.6 Percent change from baseline
Standard Deviation 14.3
|
1 Percent change from baseline
Standard Deviation 31.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Once a week during the second of the three weekly sessions specimens will be taken at the 60 and 240 minutes timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis..Measure of the % change from Baseline for the hemocompatibility marker Thrombin/Antithrombin complex for the Optiflux, Revaclear, and ELISIO dialyzers.
Outcome measures
| Measure |
BUN Clearance Optiflux
n=7 Participants
Solute clearance at 60 minutes for urea
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Revaclear
n=9 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Elisio
n=6 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance Optiflux
n=8 Participants
Solute clearance at 60 minutes for creatinine.
|
Creatinine Clearance Revaclear
n=9 Participants
Solute clearance at 60 minutes for creatinine.
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance ELISIO
n=9 Participants
Solute clearance at 60 minutes for creatinine,
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Phosphate Clearance Optiflux
Phosphate clearance at 60 minutes
|
Phosphate Clearance Revaclear
Phosphate Clearance at 60 minutes.
|
Phosphate Clearance Elisio
Phosphate Clearance at 60 minutes.
|
Beta 2 Microglobulin Revaclear
Beta 2 microglobulin clearance at 60 minutes
|
Beta 2 Microglobulin Optiflux
Beta 2 microglobulin clearance at 60 minutes.
|
Beta 2 Microglobulin ELISIO
Beta 2 Microglobulin clearance at 60 minutes.
|
Myoglobin Clearance Optiflux
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance Revaclear
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance ELISIO
Myoglobin clearance at 60 minutes.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers.
|
35.8 % Change from Baseline
Standard Deviation 99.5
|
-16.4 % Change from Baseline
Standard Deviation 44.3
|
52.7 % Change from Baseline
Standard Deviation 50.4
|
895.3 % Change from Baseline
Standard Deviation 755.0
|
474.7 % Change from Baseline
Standard Deviation 393.9
|
545.2 % Change from Baseline
Standard Deviation 573.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Once a week during the second of three weekly sessions samples will be taken at the 0, 15, 30, 60, and 240 minute timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis.Measure of the % change from Baseline for the hemocompatibility marker Hematocrit for the Optiflux, Revaclear, and ELISIO dialyzers.
Outcome measures
| Measure |
BUN Clearance Optiflux
n=9 Participants
Solute clearance at 60 minutes for urea
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Revaclear
n=10 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Elisio
n=9 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance Optiflux
n=9 Participants
Solute clearance at 60 minutes for creatinine.
|
Creatinine Clearance Revaclear
n=10 Participants
Solute clearance at 60 minutes for creatinine.
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance ELISIO
n=9 Participants
Solute clearance at 60 minutes for creatinine,
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Phosphate Clearance Optiflux
n=9 Participants
Phosphate clearance at 60 minutes
|
Phosphate Clearance Revaclear
n=10 Participants
Phosphate Clearance at 60 minutes.
|
Phosphate Clearance Elisio
n=9 Participants
Phosphate Clearance at 60 minutes.
|
Beta 2 Microglobulin Revaclear
n=9 Participants
Beta 2 microglobulin clearance at 60 minutes
|
Beta 2 Microglobulin Optiflux
n=10 Participants
Beta 2 microglobulin clearance at 60 minutes.
|
Beta 2 Microglobulin ELISIO
n=9 Participants
Beta 2 Microglobulin clearance at 60 minutes.
|
Myoglobin Clearance Optiflux
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance Revaclear
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance ELISIO
Myoglobin clearance at 60 minutes.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
|
-5.8 Percent change from baseline.
Standard Deviation 6.2
|
-3.2 Percent change from baseline.
Standard Deviation 6.1
|
-4.2 Percent change from baseline.
Standard Deviation 4.4
|
-3.8 Percent change from baseline.
Standard Deviation 3.7
|
-2.1 Percent change from baseline.
Standard Deviation 5.3
|
-1.0 Percent change from baseline.
Standard Deviation 5.6
|
-1.8 Percent change from baseline.
Standard Deviation 4.0
|
-3.0 Percent change from baseline.
Standard Deviation 6.7
|
0.03 Percent change from baseline.
Standard Deviation 5.6
|
0.8 Percent change from baseline.
Standard Deviation 7.0
|
1.9 Percent change from baseline.
Standard Deviation 6.5
|
2.0 Percent change from baseline.
Standard Deviation 8.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time points. Measurements for all patients were summed for each dialyzer type and time point for analysis.Measure of the % change from Baseline for the hemocompatibility marker Hemoglobin for the Optiflux, Revaclear, and ELISIO dialyzers.
Outcome measures
| Measure |
BUN Clearance Optiflux
n=9 Participants
Solute clearance at 60 minutes for urea
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Revaclear
n=10 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Elisio
n=9 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance Optiflux
n=9 Participants
Solute clearance at 60 minutes for creatinine.
|
Creatinine Clearance Revaclear
n=10 Participants
Solute clearance at 60 minutes for creatinine.
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance ELISIO
n=9 Participants
Solute clearance at 60 minutes for creatinine,
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Phosphate Clearance Optiflux
n=9 Participants
Phosphate clearance at 60 minutes
|
Phosphate Clearance Revaclear
n=10 Participants
Phosphate Clearance at 60 minutes.
|
Phosphate Clearance Elisio
n=9 Participants
Phosphate Clearance at 60 minutes.
|
Beta 2 Microglobulin Revaclear
n=9 Participants
Beta 2 microglobulin clearance at 60 minutes
|
Beta 2 Microglobulin Optiflux
n=10 Participants
Beta 2 microglobulin clearance at 60 minutes.
|
Beta 2 Microglobulin ELISIO
n=9 Participants
Beta 2 Microglobulin clearance at 60 minutes.
|
Myoglobin Clearance Optiflux
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance Revaclear
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance ELISIO
Myoglobin clearance at 60 minutes.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
|
-2.3 Percent Change from Baseline
Standard Deviation 2.0
|
-1.8 Percent Change from Baseline
Standard Deviation 3.0
|
-2.3 Percent Change from Baseline
Standard Deviation 1.6
|
-2.2 Percent Change from Baseline
Standard Deviation 1.9
|
-1.1 Percent Change from Baseline
Standard Deviation 2.7
|
-2.7 Percent Change from Baseline
Standard Deviation 2.1
|
-0.9 Percent Change from Baseline
Standard Deviation 2.7
|
-1.2 Percent Change from Baseline
Standard Deviation 2.8
|
-1.7 Percent Change from Baseline
Standard Deviation 2.3
|
2.3 Percent Change from Baseline
Standard Deviation 5.2
|
4.3 Percent Change from Baseline
Standard Deviation 4.3
|
2.4 Percent Change from Baseline
Standard Deviation 4.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point.Measure of the % change from Baseline for the hemocompatibility marker White Cell Count for the Optiflux, Revaclear, and ELISIO dialyzers.
Outcome measures
| Measure |
BUN Clearance Optiflux
n=9 Participants
Solute clearance at 60 minutes for urea
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Revaclear
n=10 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Elisio
n=9 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance Optiflux
n=9 Participants
Solute clearance at 60 minutes for creatinine.
|
Creatinine Clearance Revaclear
n=10 Participants
Solute clearance at 60 minutes for creatinine.
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance ELISIO
n=9 Participants
Solute clearance at 60 minutes for creatinine,
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Phosphate Clearance Optiflux
n=9 Participants
Phosphate clearance at 60 minutes
|
Phosphate Clearance Revaclear
n=10 Participants
Phosphate Clearance at 60 minutes.
|
Phosphate Clearance Elisio
n=9 Participants
Phosphate Clearance at 60 minutes.
|
Beta 2 Microglobulin Revaclear
n=9 Participants
Beta 2 microglobulin clearance at 60 minutes
|
Beta 2 Microglobulin Optiflux
n=10 Participants
Beta 2 microglobulin clearance at 60 minutes.
|
Beta 2 Microglobulin ELISIO
n=9 Participants
Beta 2 Microglobulin clearance at 60 minutes.
|
Myoglobin Clearance Optiflux
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance Revaclear
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance ELISIO
Myoglobin clearance at 60 minutes.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
|
-8.1 Percent Change from Baseline
Standard Deviation 8.0
|
-5.8 Percent Change from Baseline
Standard Deviation 7.4
|
-10.1 Percent Change from Baseline
Standard Deviation 7.5
|
-5.5 Percent Change from Baseline
Standard Deviation 6.5
|
-0.8 Percent Change from Baseline
Standard Deviation 6.2
|
-2.9 Percent Change from Baseline
Standard Deviation 8.2
|
-3.9 Percent Change from Baseline
Standard Deviation 6.2
|
-2.4 Percent Change from Baseline
Standard Deviation 5.1
|
-3.8 Percent Change from Baseline
Standard Deviation 5.3
|
-3.2 Percent Change from Baseline
Standard Deviation 12.4
|
2.9 Percent Change from Baseline
Standard Deviation 9.5
|
-0.06 Percent Change from Baseline
Standard Deviation 6.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point.Measure of the % change from Baseline for the hemocompatibility marker Platelets for the Optiflux, Revaclear, and ELISIO dialyzers.
Outcome measures
| Measure |
BUN Clearance Optiflux
n=9 Participants
Solute clearance at 60 minutes for urea
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Revaclear
n=10 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
BUN Clearance Elisio
n=9 Participants
Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance Optiflux
n=9 Participants
Solute clearance at 60 minutes for creatinine.
|
Creatinine Clearance Revaclear
n=10 Participants
Solute clearance at 60 minutes for creatinine.
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Creatinine Clearance ELISIO
n=9 Participants
Solute clearance at 60 minutes for creatinine,
ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
|
Phosphate Clearance Optiflux
n=9 Participants
Phosphate clearance at 60 minutes
|
Phosphate Clearance Revaclear
n=10 Participants
Phosphate Clearance at 60 minutes.
|
Phosphate Clearance Elisio
n=9 Participants
Phosphate Clearance at 60 minutes.
|
Beta 2 Microglobulin Revaclear
n=9 Participants
Beta 2 microglobulin clearance at 60 minutes
|
Beta 2 Microglobulin Optiflux
n=10 Participants
Beta 2 microglobulin clearance at 60 minutes.
|
Beta 2 Microglobulin ELISIO
n=9 Participants
Beta 2 Microglobulin clearance at 60 minutes.
|
Myoglobin Clearance Optiflux
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance Revaclear
Myoglobin clearance at 60 minutes.
|
Myoglobin Clearance ELISIO
Myoglobin clearance at 60 minutes.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
|
-6.2 Percent Change from Baseline
Standard Deviation 3.9
|
-3.1 Percent Change from Baseline
Standard Deviation 4.1
|
-3.9 Percent Change from Baseline
Standard Deviation 5.0
|
-5.0 Percent Change from Baseline
Standard Deviation 6.2
|
-1.5 Percent Change from Baseline
Standard Deviation 4.5
|
-9.1 Percent Change from Baseline
Standard Deviation 6.6
|
-4.4 Percent Change from Baseline
Standard Deviation 7.8
|
-4.8 Percent Change from Baseline
Standard Deviation 5.3
|
-7.3 Percent Change from Baseline
Standard Deviation 5.6
|
-2.0 Percent Change from Baseline
Standard Deviation 7.5
|
0.7 Percent Change from Baseline
Standard Deviation 12.2
|
-1.2 Percent Change from Baseline
Standard Deviation 12.3
|
—
|
—
|
—
|
Adverse Events
Experimental: ELISIO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Revaclear
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Optiflux
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Madhukar Misra, MD
University of Missouri, Department of Medicine, Division of Nephrology
Phone: 573 882-7993
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place