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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Diacap Pro High-Flux
1.3/ 1.6/ 1.9 sqm
干预措施: Diacap Pro High-Flux (Device)
结局指标
主要结局
Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF)
时间窗: 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.
次要结局
- 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)