NCT04395911已完成不适用
A Multi-Center Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Patients Developing Acute Kidney Injury (AKI) or Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 Infection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Dialysis Dependency
研究概览
简要总结
Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained
- •Positive COVID-19 test
- •Must be receiving medical care in an intensive care nursing situation
- •Non-pregnant females
- •Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
- •Platelet count >30,000/mm3 at Screening
- •Clinical diagnosis of AKI requiring CRRT or ARDS
排除标准
- •Cardiovascular instability that precludes initiation of continuous renal replacement therapy (CRRT).
- •Irreversible brain damage based on available historical and clinical information.
- •Presence of any solid organ transplant at any time.
- •Patients with stem cell transplant in the previous 100 days or who have not engrafted.
- •Acute or chronic use of circulatory support device other than ECMO such as LVADs, RVADs, BIVADs.
- •Metastatic malignancy which is actively being treated or may be treated with chemotherapy or radiation during the subsequent three month period after study treatment.
- •Chronic immunosuppression defined as >20 mg prednisone qd alone without other immunosuppressant medications (ie (cyclophosphamide, azathioprine, methotrexate, rituximab, mycophenolate, cyclosporine).
- •Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
- •Concurrent enrollment in another interventional clinical trial. Patients enrolled in observational studies (NO TEST DEVICE OR DRUG USED) are allowed to participate.
- •Any reason the Investigator deems exclusionary.
结局指标
主要结局
Dialysis Dependency
时间窗: 60 days post treatment
Dialysis Dependency at Day 60
Mortality at Day 60
时间窗: 60 days post treatment
All cause mortality at Day 60
Ventilation at Day 28
时间窗: 28 days post treatment
Ventilation free survival at Day 28
次要结局
- SCD Integrity(10 days of treatment)
- P02/FiO2 change(10 days of treatment)
- Safety Assessments(10 days of treatment)
- Urinary output change(10 days of treatment)
- Dialysis Dependency(28 days post treatment)
- Mortality at Day 28(28 days post treatment)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal FailureAcute Renal FailureNCT01072682SeaStar Medical35
终止
不适用
A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKIAcute Kidney InjuryNCT04869787Children's Hospital Medical Center, Cincinnati7
终止
不适用
Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney InjuryAcute Kidney InjuryNCT01400893SeaStar Medical134
已完成
不适用
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).Acute Kidney InjuryNCT02820350CytoPherx, Inc19
撤回
不适用
CytoSorb® in Patients With Acute on Chronic Liver FailureAcute on Chronic Liver FailureAlcoholic HepatitisNCT05131230CytoSorbents Europe GmbH