A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients

University of Missouri (MU)

Status: Completed

Conditions: End Stage Renal Disease (ESRD)

Treatments: Device: Revaclear; Device: Optiflux; Device: ELISIO-15H

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02433210

2002150

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 3 patient groups

Solute Clearance

Active Comparator group

Description:

Solute clearance at 60 minutes for urea, creatinine, phosphate, beta 2 microglobulin, and myoglobin will be determined three times for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers at the 60 minute time point.

Treatment:

Device: ELISIO-15H

Device: Optiflux

Device: Revaclear

Hemocompatibility

Active Comparator group

Description:

Hemocompatibility will be determined using the markers C3a, C5a, thrombin/anti-thrombin complex and complete blood count with platelets will be determined one time for each dialyzer at session 2 and at time points 0, 15, 30, 60, and 240 minutes for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers ..

Treatment:

Device: ELISIO-15H

Device: Optiflux

Device: Revaclear

Solute removal rate

Active Comparator group

Description:

Solute (urea, creatinine, phosphate, beta 2 macroglobulin, and myoglobin) removal rate will be determined time points 0 and 240 minutes for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers .

Treatment:

Device: ELISIO-15H

Device: Optiflux

Device: Revaclear