Blood Flow Effects on Silicon Substrates
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- effects of the hemocartridge materials on inflammatory and coagulation factors in blood
研究概览
简要总结
This is a non-randomized, open label, uncontrolled first in human safety study, testing the the material used in the artificial kidney device in subjects already on hemodialysis.
Six subjects already on hemodialysis, who meet the study inclusion and exclusion criteria, and who dialyze at one of the UCSF associated hemodialysis units will be recruited. Each subject will be tested during one non hemodialysis day, at the UCSF Moffitt-Long Hospital Acute Hemodialysis Unit (AHU).
The artificial kidney engineers have created a blood flow system that can be substituted for the dialysis filter in a standard hemodialysis machine. This is NOT a dialysis filter. It allows the subjects blood to come in contact with the material while the blood is being circulated as is regularly done during a hemodialysis session.
详细描述
For patient safety, the investigators will measure the following labs:
Blood tests (routine safety and frequency). CBC/platelets: q 1 hr, at HD next day ABGs, including lactate: Q 1 hr x 6 Na, K, Cl, Bicarb, BUN, Creatinine, Ca, ionized Ca, Mg, Phos: Start, end, at HD next day Liver function test: Start, end, at HD next day LDH: Start, end, at HD next day Direct Coombs' Test: Start, end, at HD next day ESR and hsCRP: Start, end, at HD next day CPK: Start, end PT/PTT: Start, end
The investigators will also be doing research blood testing:
IL-6: Start, end, at HD next day Complement: Start, end, at HD next day Haptoglobin: Start, end, at HD next day Free Hg: Start, end, at HD next day Fibrinogen, D-dimer: Start, end, at HD next day
In addition, the investigators will do material testing after each participant's test is complete.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 y/o
- •ESRD on hemodialysis for at least 3 months
- •HD access capable of sustaining at least 300 ml/min blood flow
- •Hg > 10.0 g
- •Able to take aspirin 81 mg/day for a week prior to the study (for those subjects not already on aspirin)
- •Able to read, speak and understand English
- •Capable of providing signed informed consent
- •HD pt at one of the UCSF outpatient HD units
排除标准
- •Subjects with active liver, cardiovascular, neurologic or psychiatric diseases
- •Subjects with other active medical problems (e.g., cancer undergoing treatment)
- •h/o intradialytic or orthostatic hypotension
- •h/o thrombosis or on treatment for thrombosis or use of anticoagulants, excluding antiplatelet agents
- •h/o active infection or on antibiotics
- •h/o active autoimmune diseases or other inflammatory states
- •Ongoing alcohol or illegal drug use
- •H/o hemolysis or allergic reactions to any dialyzers
- •Anyone who in the opinion of the study doctors is not qualified to be in the study.
结局指标
主要结局
effects of the hemocartridge materials on inflammatory and coagulation factors in blood
时间窗: 6 months
Aim 2: To prove that this material is does not induce inflammatory or coagulation effects nor induce hemolysis. The investigators will do this by drawing blood before, during and after the procedure for inflammatory markers and coagulation factors. The investigators will also evaluate whether any evidence of mechanical dysfunction, such as hemolysis occurs during the treatment. See the detailed study description for the listing and timing of the tests. 1.c. evaluation of mechanical dysfunction
material stability
时间窗: 6 months
This is a first in human safety study, testing the safety of the material used in the artificial kidney device in subjects already on hemodialysis. Specific aims include: Aim 1: To prove that blood does not degrade the material (see study description for details of processes used) 1.a. by evaluating the effect on surface roughness via scanning electron microscopy of the hemocartridge plates 1. b. by studying the effect on film thickness via scanning electron microscopy and immunohistochemistry for platelet adhesion.
次要结局
未报告次要终点