NCT02111018撤回2 期
Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Efficacy of device as measured by change in myoglobin
研究概览
简要总结
Prospective, randomized non-blinded, controlled study to assess the feasibility of the CytoSorb as an adjunct to the standard of care in patients with rhabdomyolysis requiring renal replacement therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is age 18-80
- •Subjects present with rhabdomyolysis
- •Subject requires renal replacement therapy and has undergone adequate volume resuscitation
- •Subject is willing to comply with specified follow up requirements
排除标准
- •Subject or their legal guardian either declines or cannot give informed consent
- •Subject is pregnant
- •Subject has been previously enrolled in this clinical study
- •Comorbid condition that may limit survival to ≤14 days
- •Comorbid condition that could confound study results
- •Subjects who are receiving immunosuppressive therapy
结局指标
主要结局
Efficacy of device as measured by change in myoglobin
时间窗: 30 days
Assessment of serious device or procedure-related adverse events
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (2)
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