nctId: NCT06351150 id: TQG3902-III-01 briefTitle: Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-06 date: 2027-12 date: 2024-04-08 date: 2024-04-08 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled study on the treatment of refractory distributed shock with angiotensin II injection, with a random ratio of 1:1. Assuming a success rate of 25% for the main therapeutic endpoint in the control group and 50% for the experimental group, a total of 214 subjects will be enrolled, including 107 in the experimental group and 107 in the control group. conditions: Vasodilatory Shock studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 214 type: ESTIMATED name: Angiotensin II Injection name: 0.9% sodium chloride injection measure: Proportion of subjects with blood pressure response at 3 hours after administration of study drug measure: Sequential Organ Failure Assessment (SOFA) total score measure: Cardiovascular SOFA subscore measure: Mortality at Day 7 measure: Mortality at Day 28 measure: Proportion of subjects with blood pressure response at 1 hour after administration measure: Proportion of subjects with blood pressure response at 2 hours after administration measure: Change in background vasoactive agent dose from 0 to 48 hours measure: Absolute change in blood lactate from 0 to 3 hours measure: Absolute change in blood lactate from 3 to 48 hours measure: Absolute change in heart rate from 0 to 3 hours measure: Absolute change in heart rate from 3 to 48 hours measure: Adverse events (AE) measure: Serious adverse events (SAE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China name: Yun Long, M.D. role: CONTACT phone: 13911608699 email: yunlongxh@163.com lat: 39.9075 lon: 116.39723 facility: The First Affiliated Hospital of Sun Yat sen University city: Guangzhou state: Guangdong zip: 510062 country: China name: Xiangdong Guan, M.D. role: CONTACT phone: 13802925067 email: guanxiangdong1962@163.com lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University city: Guangzhou state: Guangdong zip: 510260 country: China name: Zhanguo Liu, M.D. role: CONTACT phone: 18520711669 email: zhguoliu@163.com lat: 23.11667 lon: 113.25 facility: Qingyuan Hospital Affiliated to Guangzhou Medical University city: Qingyuan state: Guangdong zip: 511518 country: China name: Jingwen Yang, M.D. role: CONTACT phone: 13542498765 email: 00655@qyry.com lat: 23.7 lon: 113.03333 facility: The First Affiliated Hospital of Shantou University Medical College city: Shantou state: Guangdong zip: 515041 country: China name: Yongru Chen, M.D. role: CONTACT phone: 13411969797 email: ongruchen@126.com lat: 23.36814 lon: 116.71479 facility: Liuzhou General Hospital city: Liuzhou state: Guangxi zip: 545026 country: China name: Guangyu Lv, M.D. role: CONTACT phone: 13977210130 email: lgy197823@163.com facility: The Affiliated Hospital of Hebei University city: Baoding state: Hebei zip: 050031 country: China name: Zhanbiao Yu, M.D. role: CONTACT phone: 15188655821 email: daxiang285@sina.com lat: 38.85111 lon: 115.49028 facility: The First Affiliated Hospital of Harbin Medical University city: Harbin state: Heilongjiang zip: 150007 country: China lat: 45.75 lon: 126.65 facility: The First Affiliated Hospital of Bengbu Medical College city: Bengbu state: Henan zip: 233099 country: China name: Yongsheng Zheng, M.D. role: CONTACT phone: 13955252796 email: zsy0916@163.com lat: 32.94083 lon: 117.36083 facility: The First Affiliated Hospital of Henan University of Science and Technology city: Luoyang state: Henan zip: 450052 country: China name: Qizhi Fu, M.D. role: CONTACT phone: 13837944687 email: fuqizhi33@sina.com lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Zhengzhou University city: Zhengzhou state: Henan zip: 450052 country: China name: Tongwen Sun, M.D. role: CONTACT phone: 13838516916 email: suntongwen@163.com lat: 34.75778 lon: 113.64861 facility: Union Hospital, Tongji Medical College of huazhong university of science and technology city: Wuhan state: Hubei zip: 430022 country: China name: You Shang, M.D. role: CONTACT phone: 15972127819 email: you_shanghust@163.com lat: 30.58333 lon: 114.26667 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 140008 country: China name: Lina Zhang, M.D. role: CONTACT phone: 15874875763 email: zln7095@163.com lat: 28.19874 lon: 112.97087 facility: Jiangsu Province Hospital city: Nanjing state: Jiangsu zip: 210029 country: China name: Quan Cao, M.D. role: CONTACT phone: 13851992695 email: 2004caoquan@163.com lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xi'an state: Shaanxi zip: 710004 country: China name: Xiaochuang Wang, M.D. role: CONTACT phone: 13772152935 email: 1585431074@qq.com lat: 34.25833 lon: 108.92861 facility: The First Hospital of Shanxi Medical University city: Taiyuan state: Shanxi zip: 030001 country: China name: Jing Cao, M.D. role: CONTACT phone: 13834691242 email: 13834691242@163.com lat: 37.86944 lon: 112.56028 facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610044 country: China name: Yan Kang, M.D. role: CONTACT phone: 13808041931 email: kangyan_hx@163.com lat: 30.66667 lon: 104.06667 facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 610072 country: China name: Xiaobo Huang, M.D. role: CONTACT phone: 18140049936 email: drhuangxb@163.com lat: 30.66667 lon: 104.06667 facility: The First Affiliated Hospital of Xinjiang Medical University city: Ürümqi state: Xinjiang zip: 830054 country: China name: Xiangyou Yu, M.D. role: CONTACT phone: 13009681003 email: yu2796@163.com lat: 43.80096 lon: 87.60046 hasResults: False