Determination of the In-vivo Ultrafiltration Coefficient and Evaluation of Performance, Hemo- and Biocompatibility- and Safety-data of High Flux Hemodialyser Diacap Pro in Patients With End Stage Renal Disease on Chronic Hemodialysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- B.Braun Avitum AG
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF)
Study Overview
Brief Summary
The main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States.
Detailed Description
The in-vivo KUF for Diacap Pro High Flux dialysers with the surface sizes of 1.3/ 1.6/ 1.9 sqm will be determined as required by the US guideline "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers 1998" for comparison with the in-vitro KUF data.
Clinical data of at least 12 patients will be collected for determination of the in-vivo KUF complemented by safety-, performance-data for the removal of small and middle molecular substances and hemocompatibility data.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent obtained from patient or parents/ guardian.
- •Subject age > 18
- •Effective blood flow 350 ml/min and dialysate flow in the range of 500 - 800 ml/min
- •On hemodialysis for a minimum of 3 months
- •Use of Cimino- or Gore-tex shunts
- •Routine dialysis-treatment for 240 min and 3 times per week
- •Documented dialysis adequacy parameter spKt/V >=1.2 that has been stable for past 3 months
- •Plan to dialyze at participating hemodialysis center for at least 3-months duration.
- •Free from any currently known unusual clotting or access problems
- •Hepatitis B surface antigen (HbsAg) negative, documented within the past 90 days or Hepatitis B surface antibody (anti-HBs) positive.
- •Anti HCV negative, documented within the past 90 days
- •Anti HIV negative, documented within the past 90 days Hematocrit (HCT) between 25 and 40% or haemoglobin (Hb) not less than 8 g/dL
Exclusion Criteria
- •Patients who are unable to tolerate an effective blood flow of 350 ml/min
- •Patients using catheter for dialysis
- •Pregnant or nursing woman. Women of childbearing potential must agree to avoid pregnancy during the study period
- •Previous plan for extended absences from the participating hemodialysis centre
- •Expected to be transplanted (living related donor) within the maximum of 3 months for the study period
- •Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
Outcomes
Primary Outcomes
Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF)
Time Frame: For two of three dialysis sessions each week for a total study period of six weeks
UF-rates will be changed over a range starting from 600 ml/min to 1000 ml/min to 1400 ml/min to finally 1800 ml/min and resulting changes in Transmembrane Pressure (TMP) will be documented.
Secondary Outcomes
- Reduction rates dialyzer [%](For two of three dialysis sessions each week for a total study period of six weeks)
- Complement-activation C3a and C5a [ng/ml](For one of six dialysis sessions each two weeks for a total study period of six weeks)
- Clearance data dialyzer [ml/min](For one of six dialysis sessions each two weeks for a total study period of six weeks)
- Total removal of proteins [mg/session](For one of six dialysis sessions each two weeks for a total study period of six weeks)
- Complement-activation TAT III [µg/l](For one of six dialysis sessions each two weeks for a total study period of six weeks)
- Inflammatory response Interleukin-1, Interleukin-6 and TNF-alpha [pg/ml](For one of six dialysis sessions each two weeks for a total study period of six weeks)
- Inflammatory response CRP [mg/l](For one of six dialysis sessions each two weeks for a total study period of six weeks)
- Incidence of Treatment-Emergent Adverse Events(November 2016 up to 2 months)