ITMCTR1900002654招募中4 期
A randomized controlled trial for the efficacy and safety of injection of Yiqi Fumai for septic shock and cardiogenic shock
The Second Affiliated Hospital of Guangzhou University 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
- 4 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
- 性别
- All
入选标准
- •(1) patients with septic shock
- •1) all the patients met the clinical diagnostic criteria for septic shock, with clear infection foci and the growth of pathogenic microorganisms in blood culture;
- •2) body temperature over 38.5 degree C or below 35 degree C;
- •3) hypoperfusion of tissues and organs, urine volume less than 0.5ml /(h.kg);
- •4) systolic blood pressure lower than 90 mmHg;
- •5) SOFA score greater than 2,
- •6) vasoactive drugs are required to maintain MAP 65mmHg; Blood lactic acid tendency for L > 2.
- •7) all patients or their families have given informed consent and signed informed consent forms;
- •8) complete clinical diagnosis and treatment data and follow-up data.
- •(2) patients with cardiogenic shock: according to the guidelines for diagnosis and treatment of cardiogenic shock formulated in 2010.
- •1) patients with a history of acute myocardial infarction, acute myocarditis, primary or secondary cardiomyopathy, severe malignant arrhythmia, drug poisoning with myocardial toxicity, acute cardiac compression and cardiac surgery;
- •2) in the early stage, the patient was agitated, pale, complained of dry mouth and sweating, but still had a clear mind; Gradually after the expression of indifference, fuzzy consciousness, delirious until coma;
- •3) the heart rate gradually increased during physical examination, often > 120 times /min. Systolic blood pressure < 80 mmHg, pulse pressure difference < 20mmHg, then gradually decreased, serious blood pressure can not be measured. A weak pulse, cold extremities, cyanosis of the extremities, and variegated skin. Heart tone low pure, serious show single tone. Urine volume < 17mL/h, or even no urine. In the late stage of shock, extensive bleeding of skin, mucosa and viscera, i.e. diffuse intravascular coagulation, and multiple organ failure occurred.
- •4) hemodynamic monitoring suggested the corresponding hemodynamic abnormalities such as decreased cardiac index and increased left ventricular end-diastolic pressure.
- •5) patients aged between 18 and 70 years.
排除标准
- •(1) confirmed chronic uremia or died or left the hospital 24 hours after admission;
- •(2) patients with severe cirrhosis, advanced tumors or abnormal coagulation;
- •(3) patients with a history of stress ulcer or severe craniocerebral injury within 6 months;
- •(4) autoimmune diseases and malignant tumors;
- •(5) allergic to red ginseng, radix ophiopogonis, schisandrae and other traditional Chinese medicines and injection preparations.
研究者
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