Hemofiltration in Acute Ischemic Stroke Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 主要终点
- Safety monitoring for adverse events
研究概览
简要总结
Ischemic stroke is accompanied by a three to four hundred percent increase in the brain's extracellular fluid (ECF) and cerebrospinal fluid (CSF) concentration of glutamate, which diffuses and damages surrounding neurons. In this study we tested our hypothesis that blood glutamate levels can be reduced by hemofiltration, resulting in increased extracellular clearance of glutamate and attenuated neurodegeneration, and that decreased blood glutamate levels can provide significant neuroprotection against stroke-associated neurodegeneration, dysfunction and death. Our primary outcome of interest was to assess safety of hemofiltration in acute ischemic stroke patients.
详细描述
Ethical Conduct of the Study
Investigator Responsibilities
The principle investigator was responsible for monitoring and responding to adverse events, ethical participant use, compliance with the protocols and any protocol amendments, decisions to end the study early and compliance with data and sample management protocols. CO-PI was trained in both local and international requirements and standards and assisted and report to the PI on these tasks.
Participant Selection and Enrollment
Eligible participants were identified by medical staff at the ICU or emergency department. Enrollment will be standardized and directed by Co-PI.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 year-old; both males and females;
- •Diagnosis of acute ischemic stroke verified by CT or MRI and moderate to severe disability (NIHSS 5-21 points, GCS > 4 points and < 12);
- •Able to start hemofiltration treatment within 12 hours of stroke onset.;
- •Signed written informed consent in either Kazakh or Russian.
排除标准
- •Age below 18 years or above 75 years;
- •Presentation over 12 hours from stroke onset;
- •Decompensated coronary heart disease (unstable angina, acute myocardial infarction, heart failure - according to New York or Canadian classification, 3, blood disorders, known coagulopathy, platelet count less than75 000 / mmc;
- •Pulmonary edema, shock, hemodynamic instability;
- •Intracranial hemorrhage or lesions (brain abscess, tumors);
- •Inability to obtain informed consent;
- •Contraindications for CT.
研究组 & 干预措施
Hemofiltration (treatment)
Standard acute ischemic stroke treatment + hemofiltration Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg)
干预措施: Hemofiltration (Device)
Hemofiltration (treatment)
Standard acute ischemic stroke treatment + hemofiltration Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg)
干预措施: Standard acute ischemic stroke treatment (Procedure)
Control
Standard acute ischemic stroke treatment Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg)
干预措施: Standard acute ischemic stroke treatment (Procedure)
结局指标
主要结局
Safety monitoring for adverse events
时间窗: 28 days
The patients were screened continuously for the following adverse events: death, bleeding disorders, hemorrhagic transformation of acute ischemic stroke, central line-related blood stream infection, cardiac dysrhythmia within 28 days
次要结局
未报告次要终点
研究者
Dmitriy Viderman
Attending anesthesiologist & intensivist
University Medical Center, Kazakhstan