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