N/A
N=11
A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients
End Stage Renal Disease (ESRD)
Bottom Line
View on ClinicalTrials.gov: NCT02433210 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Clearance and Solute Removal Characteristics of Dialyzers — 354.1; 340.4; 361.8; 271.8 milliliters per minute (ml/min) — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ELISIO-15H (Device); Revaclear (Device); Optiflux (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clearance and Solute Removal Characteristics of Dialyzers |
354.1; 340.4; 361.8; 271.8; 295.9; 298.4 | <0.001 sig |
| PRIMARY Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers |
8.5; -5.1; -4.5; 11.2; 7.5; -1.1 | =0.216 |
| PRIMARY Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers. |
35.8; -16.4; 52.7; 895.3; 474.7; 545.2 | =0.204 |
| PRIMARY Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers |
-5.8; -3.2; -4.2; -3.8; -2.1; -1.0 | =0.376 |
| PRIMARY Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers |
-2.3; -1.8; -2.3; -2.2; -1.1; -2.7 | =0.670 |
| PRIMARY Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers |
-8.1; -5.8; -10.1; -5.5; -0.8; -2.9 | =0.534 |
| PRIMARY Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers |
-6.2; -3.1; -3.9; -5.0; -1.5; -9.1 | =0.114 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02433210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.