NCT01726868Unknown2 期
Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
Japan Community Health Care Organization Sendai Hospital2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Incidence of chronic hemodialysis
研究概览
简要总结
The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all of the following criteria.
- •Patients who had cardiac catheterization or vascular surgery in the last 24 weeks before the time of obtaining informed consent.
- •Patients who satisfy all of the following criteria or are diagnosed as CCE by skin or renal biopsy.
- •Patients with progressive renal dysfunction in the course of weeks or months.
- •Patients with skin lesions such as livedo reticularis of lower extremities or blue toe syndrome.
- •Eosinophil count is more than 400 per microliter.
- •Patients who or patients whose legal representative understood the requirements of the study and signed the informed consent forms.
排除标准
- •Patients who meet any of the following criteria will be excluded.
- •Patients with contraindication to anticoagulant (Nafamostat Mesilate).
- •Blood purification therapy is inapplicable because of severe heart failure, acute myocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollable hypertension or hypotension.
- •Patients with body weight less than 40kg.
- •Patients with a history of allergic reaction or hypersensitivity to blood purification.
- •Patients who cannot stop taking ACE inhibitors.
- •Patients with any disease in which corticosteroid, statin are contraindicated.
- •Patients participated in another clinical trial or study at the time of obtaining informed consent.
- •Patients receiving chronic hemodialysis.
- •Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
结局指标
主要结局
Incidence of chronic hemodialysis
时间窗: Six months
次要结局
- Dose of drugs(Six months)
- Incidence of lower limb amputation(Six months)
- Incidence of gangrene(Six months)
- Incidence of adverse events(Six months)
- Incidence of multi organ failure(Six months)
- Survival rate(Six months)
研究者
TOSHINOBU SATO
MD, PhD
Japan Community Health Care Organization Sendai Hospital
研究点 (2)
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