ITMCTR2000003566招募中1 期
The clinical trial of the interventional effect of Sini Decoction and Shengxian Quyu Decoction on myocardial inhibition in patients with sepsis
Guangdong Provincial Hospital of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 85（—）
- 性别
- All
入选标准
- •Diagnostic criteria of Western medicine:
- •1. Patients with sepsis: (refer to the latest sepsis diagnostic criteria developed by SSC guidelines in 2016)
- •(1) Suspected or confirmed infection;
- •(2) The sequential organ failure score (SOFA score) increased by 2 or more points above the baseline level, and it could be diagnosed as sepsis.
- •2. Myocardial suppression: at present, there is no unified diagnostic standard for sepsis myocardial injury at home and abroad. At present, the domestic and foreign literatures are consulted and the diagnosis process recognized by well-known experts is followed. The presence of any of the following is suggestive of myocardial suppression:
- •(1) Myocardial injury markers: c-tni > 0.03ng/ml and c-tnt > 0.017ng/ml.
- •(2) Echocardiography: LVEF < 50%, or FS > 25%.
- •Diagnostic criteria of traditional Chinese Medicine
- •(refer to the TCM classification of sepsis according to the guidelines for the treatment of severe sepsis / septic shock in China issued in 2014)
- •1. The body is tired and weak, with little Qi and lazy speech, pain in fixed parts, bleeding in some parts, and pain in chest and flank like needle pricking;
- •2. Light and dark tongue, purple purple or ecchymosis, varicose sublingual veins, and thin or stringy veins;
- •3. Cold sweat, cold limbs, red face, blue lips, or high fever, coma, etc.;
- •1. Meet the diagnostic criteria of sepsis myocardial suppression;
- •2. Syndrome differentiation of TCM is Qi deficiency and blood stasis;
- •3. Aged 18-85 years;
- •4. Excluding the patients with previous heart diseases;
- •5. Patients who voluntarily participated in the study and signed informed consent.
排除标准
- •1. Patients with severe hepatic and renal insufficiency, patients with severe immune diseases or malignant tumors;
- •2. Patients with allergic constitution or allergic to traditional Chinese medicine decoction;
- •3. Patients unable to cooperate with the study and patients who died within 24 hours after admission to ICU;
- •4. Pregnant or lactating women;
- •5. Patients who participated in other studies.
研究者
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