A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 12/22/2016 |
| Start Date: | June 2015 |
| End Date: | May 2017 |
| Contact: | MADHUKAR MISRA, MD |
| Email: | misram@health.missouri.edu |
| Phone: | 5738827992 |
A Clinical Study Comparing the Basic Performance and Blood Compatibility Characteristics of Nipro ELISIO-H, Gambro Polyflux Revaclear and Fresenius Optiflux Dialyzers
The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H
and to compare its performance characteristics and hemocompatibility with those of the
commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe.
10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood
samples for several parameters will be collected during hemodialysis to assess the
performance and hemocompatibility of the dialyzers under study. Data thus collected will be
analyzed for comparison by standard statistical analysis.
and to compare its performance characteristics and hemocompatibility with those of the
commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe.
10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood
samples for several parameters will be collected during hemodialysis to assess the
performance and hemocompatibility of the dialyzers under study. Data thus collected will be
analyzed for comparison by standard statistical analysis.
Current patients receiving dialysis treatment for end stage renal disease and who meet the
inclusion/exclusion criteria will be entered into the study. These patients will continue on
their standard dialysis regimen as stated in the clinics Standard Operating Procedures. Each
patient will be studied for three weeks with each week starting with a dialyzer of a
different manufacture but of comparable characteristics. Solute clearances and removal will
be determined at each of the three dialysis sessions during the week. During session 2 of
each week additional specimens will be taken to analyze for hemocompatibility. At the end of
the study all clearances and the hemocompatibility markers for each dialyzer will be
compared to one another as well as to the manufactures stated characteristics. Blood for the
clearance and removal calculations will be taken at time 0, 60 minutes and 240 minutes.
Blood for the hemocompatibility determinations will be taken at time 0, 15, 30, 60 and 240
minutes. Flow rates, anticoagulant therapy, erythropoietin therapy, venous and arterial
pressures will also be recorded.
inclusion/exclusion criteria will be entered into the study. These patients will continue on
their standard dialysis regimen as stated in the clinics Standard Operating Procedures. Each
patient will be studied for three weeks with each week starting with a dialyzer of a
different manufacture but of comparable characteristics. Solute clearances and removal will
be determined at each of the three dialysis sessions during the week. During session 2 of
each week additional specimens will be taken to analyze for hemocompatibility. At the end of
the study all clearances and the hemocompatibility markers for each dialyzer will be
compared to one another as well as to the manufactures stated characteristics. Blood for the
clearance and removal calculations will be taken at time 0, 60 minutes and 240 minutes.
Blood for the hemocompatibility determinations will be taken at time 0, 15, 30, 60 and 240
minutes. Flow rates, anticoagulant therapy, erythropoietin therapy, venous and arterial
pressures will also be recorded.
Inclusion Criteria:
- ESRD patients 18 years or older
- Stable on hemodialysis for more than 3 months
- Stable hemoglobin between 11-12 g/dl
- Stable arteriovenous (AV) fistula vascular access
- Stable anticoagulation and ESA regimen
- No active infection
- Able to sign informed consent and able to participate in the study
- Medically stable
Exclusion Criteria:
- Participation in another study which may interfere with the planned study
- Active infection
- Medical conditions which may interfere with the study (cardiac, liver disease,
Hepatitis)
- Allergy to dialyzer membrane materials e.g. polysulfone
- Patients which cannot tolerate Heparin
- Female who are pregnant or planning to be pregnant
- Problem with or allergy to anticoagulation
We found this trial at
1
site
Click here to add this to my saved trials
