NCT05217095已完成不适用
Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Incidence of Alarms
研究概览
简要总结
The aim of this clinical trial will be to verify the feasibility of using an impeller system instead of a roller pump for hemodialysis, using the established 4008 hemodialysis system and a Convergence Dialyzer with design changes made to the FX-Coral P 600 dialyzer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be up to 18-85 years
- •Hemodialysis Schedule: 3 times per week; app. 3- 5 hour treatment
- •Stable clinical conditions: no recent (last 2 weeks) hospitalization events, no recent main surgery (last 3 weeks), no acute cardiological problems, hemoglobine levels in the DOQI Guideline ranges.
- •Hemodynamic stability during dialysis i.c. number of sessions complicated by acute hypotension events or arrhythmia <25% in the last 3 Months
- •Well-functioning AVF vascular access: access recirculation ≤10%
- •No coagulation disorders and anticoagulant therapy
- •Patients must be using a similar size dialyzer as Convergence dialyzer
- •Signed Inform consent form.
排除标准
- •Unstable clinical condition: recent hospitalization, recent surgery, anemia, active neoplastic diseases,shock or unstable cardiac function and intolerable to extracorporeal treatment
- •Hemodynamic instability during the dialysis sessions; more than 25% of the sessions complicated by acute hypotension or arrhythmic events.Presence of clinically significant abnormality on a 12-lead ECG at Screening that, at the investigator's clinical judgment, may compromise the safety of the patient or affect the outcome of the study.
- •History or presence of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status within 6 months prior to the study Convergence system treatment.
- •Abnormal liver function values including but not limited to the aspartate transaminase, alanine transaminase or alkaline phosphatase ≥5 × upper limit normal.
- •Any uncontrolled clinically significant respiratory disease in the investigator's opinion (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, asthma).
- •Temporary excluded will be patients with increased body temperature due to some infective disease, dehydration, diarrhea, hyperglycemia,
- •Severe bleeding, or history or evidence of bleeding diathesis or coagulopathy with the risk of bleeding or have to put on dialysis without anticoagulant.
- •Using temporary or permanent dialysis catheter
- •Uncontrolled diabetes mellitus or hypertension, at the discretion of investigator.
- •Known pregnancy and lactating without pregnancy test
- •Patient has known allergy or hypersensitivity reaction to dialyzer membrane or other disposable
- •Any conditions significantly affecting the nervous system (i.e., neuropathic conditions or nervous system damage
- •Patient shows evidence of a condition (psychological, emotional problems, any disorders or resultant therapy) that is likely to invalidate health information, consent, or limit the ability of the patient to comply with the protocol requirements in the opinion of the investigator
- •Any other conditions at the discretion of investigator not suitable for patients to participate in the study
结局指标
主要结局
Incidence of Alarms
时间窗: 1 study day
Incidence of alarms leading to end of treatment, cause identification
Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect
时间窗: 1 study day
Incidence of Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect
Product defects
时间窗: 1 study day
Product defects leading to end of treatment, cause identification
Incidence of "recoverable" alarms
时间窗: 1 study day
Incidence of "recoverable" alarms, cause of alarms i.e.arterial/venous pressure outside of set range/limits
次要结局
- Arterial pressure(1 study day)
- Bicarbonate(1 study day)
- Sodium(1 study day)
- Dialysis Dose as single pool Kt/V(1 study day)
- Ultrafiltration Volume(1 study day)
- pH(1 study day)
- Average Blood Flow Rate(1 study day)
- Completion Rate(1 study day)
- Venous pressure(1 study day)
- Impeller RPM(1 study day)
- Dialysis Dose as Urea Reduction Ratio (URR)(1 study day)
- Anticoagulation(1 study day)
- Clotting Score(1 study day)
- Body weight change(1 study day)
- Potassium(1 study day)
- Chloride(1 study day)
- Free hemoglobin(1 study day)
研究者
研究点 (2)
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