NCT04970433Unknown不适用
The Effects of Electroacupuncture and Laser Acupuncture Therapy for Patients With Major Trauma
Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年10月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Length of hospital stay
研究概览
简要总结
Major trauma is a significant cause for morbidity and mortality in the world. After traumatic injury, the damage tissue could induce systemic inflammatory response (SIRS) and activate autonomic nervous system in response to stress, followed by compensatory anti-inflammatory response (CARS). Imbalance of SIRS and CARS may lead to organ failures, sepsis and death.
详细描述
The investigators design a prospective clinical trial to investigate the efficacy of acupuncture for major trauma.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 20 years or older
- •Confirmed diagnosis of major trauma with ISS ≥ 16
排除标准
- •Pregnancy
- •Malignancy
- •Pacemaker
- •Status epilepticus
- •Severe medical disease
- •Life threatening
- •Prior history of drug or alcohol dependence
- •Immunodeficiency
结局指标
主要结局
Length of hospital stay
时间窗: up to 24 weeks
Count the total days of hospitalization
次要结局
- IL-10(measured at 48 hours, 7 days and 14 days)
- Sequential organ failure assessment (SOFA) score(measured at 48 hours, 7 days and 14 days)
- CRP(measured at 48 hours, 7 days and 14 days)
- IL-6(measured at 48 hours, 7 days and 14 days)
- TNF-α(measured at 48 hours, 7 days and 14 days)
- IL-1β(measured at 48 hours, 7 days and 14 days)
- WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version(measured at 3 and 6 months)
- Peripheral Blood Mononuclear Cell (PBMC) analysis(measured at 48 hours, 7 days and 14 days)
研究者
研究点 (2)
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