NCT05982015已完成不适用
Multicenter, Randomized, Double-blind, Pseudo Treatment-controlled Clinical Study on the Efficacy and Safety of Remote Ischemic Conditioning in Preventing Stroke-associated Pneumonia
Capital Medical University1 个研究点 分布在 1 个国家目标入组 1,651 人开始时间: 2024年1月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,651
- 试验地点
- 1
- 主要终点
- Stroke-associated pneumonia
研究概览
简要总结
Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset
详细描述
Verifying whether remote ischemic adaptation can reduce the occurrence and safety of stroke related pneumonia in acute stroke patients within 24 hours of onset
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years old;
- •Diagnosis of acute ischemic stroke;
- •Remote ischemic conditioning or sham-remote ischemic conditioning can be treated within 24 hours after stroke onset
- •NIHSS score≥4;
- •Subject or his or her legally authorized representative was able to provide informed consent.
排除标准
- •During the screening period, body temperature ≥ 38 ℃;
- •Evidence of lung infection, urinary tract infection or other infectious diseases during the screening period
- •Expected lifespan less than 7 days
- •Mechanical ventilation is expected to be required within 7 days;
- •Anti-infective drug were used within 7 days prior to stroke;
- •Uncontrolled hypertension with medication (defined as systolic blood pressure ≥200 mmHg and/or diastolic blood pressure ≥110 mmHg);
- •There are contraindications for remote ischemic conditioning (such as skin and soft tissue injury, fractures, peripheral arterial disease, etc. in the upper limbs);
- •History of autoimmune disease or malignancies;
- •Use of immunosuppressive drug within the preceding 3 months;
- •Pregnant or lactating, or pregnancy test positive;
- •Current participation in another investigational trial;
- •Other conditions are not suitable for this trial as evaluated by researchers.
结局指标
主要结局
Stroke-associated pneumonia
时间窗: 7 days
Stroke-associated pneumonia incidence rate
次要结局
- Modified Rankin scale score from 0 to 1(90 days after the onset of symptoms)
- Modified Rankin scale scores(90 days)
- Physician diagnosed pneumonia(8-90 days)
- Modified Rankin scale score from 0 to 2(90 days)
- Urinary tract infections(7 days)
- Infections(7 days)
- All-cause mortality(90 days)
- EQ-5D-5L scores(90 days)
- NIHSS stroke scale scores(7 days)
- Inpatient days(90 days)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University
研究点 (1)
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