A Prospective, Multi-Center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System in Adult Patients With Chronic Renal Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Adverse Event Rate
研究概览
简要总结
The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion.
详细描述
The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion. The safety will be evaluated by comparing the adverse event rate in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control).
The study population will include eligible adult patients diagnosed with chronic renal failure requiring routine dialysis treatments for a minimum of 90 days and with a minimum of 3 weekly sessions. Treatment duration will be at the discretion of the investigator. The duration of study participation for each subject is approximately eight (8) weeks; four (4) weeks of routine dialysis and four (4) weeks of treatment dialysis. The expected total study duration across all subjects (from recruitment to last subject visits) is approximately five (5) to six (6) months, dependent upon subject recruitment/enrollment and meeting 360 evaluable treatments. A minimum of 30 eligible subjects will be enrolled into the study ensuring a minimum of 360 evaluable treatments in the treatment arm.
The sub-study, VARRM, was conducted following the subject's completion of the primary eight (8) week clinical study. The total participation time for the VARRM sub-study was approximately 1.5 weeks. Subjects that participated in the VARRM sub-study had their vascular recirculation rates collected during treatments. A minimum of 12 subjects were expected to participate in this sub-study, with a minimum of 21 and maximum of 36 dialysis accesses evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Male or female ≥18 years of age
- •Chronic renal failure diagnosis
- •Minimum of 90 days of stable hemodialysis treatment with a minimum of 3 treatment sessions per week. The duration of each treatment session is in the discretion of the investigator.
- •Reliable vascular access
- •Hemodialysis treatment a minimum of three (3) sessions per week
- •Subject agrees not to eat or drink during treatments
- •Understand and sign the informed consent form
排除标准
- •Unable to receive anticoagulation
- •Hypercoagulation diagnosis
- •Hyperviscosity diagnosis
- •Most recent hemoglobin less than 9
- •Active bacterial infection
- •Women of childbearing potential, pregnant and/or lactating females verified by urine or serum pregnancy test
- •Life expectancy less than 6 months
- •Cognitive impairment, dementia, or other condition that limits the ability to provide informed consent and to comply with study procedures, or any other reason that the Investigator believes to contraindicate study participation.
- •Current or known future need for a central venous catheter (CVC)
- •Involved in another clinical research trial within the prior 30 days
- •Diagnosed with systemic consistent hypotension as defined by being systolic <90 mm Hg or diastolic <60 mm Hg
- •Immunocompromised patients (e.g. active malignancy, current chemotherapy treatment, transplant recipients, any patient on immunosuppressive medication, or patients with current autoimmune disease).
结局指标
主要结局
Adverse Event Rate
时间窗: 8 weeks
The safety will be evaluated by comparing the adverse event rate in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control)
次要结局
- Total Colony Forming Units and Endotoxin Levels(8 Weeks)
- Fluid Balance Evaluation(8 Weeks)
研究者
Robert Provenzano, MD
Consultant -Office of Chief Medical Officer
Nikkiso America, Inc.