Vasodilatory ShockPhase 3NCT06351150
Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock
A Phase 3 study testing Angiotensin II Injection and 0.9% sodium chloride injection in people with Vasodilatory Shock, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 42 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasodilatory Shock
- What is being tested?
- Angiotensin II Injection and 0.9% sodium chloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 42 sitesChina
- Study dates
- 23 Jul 2024to Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 18 years to 75 years old, male or female;
- diagnosis of distributive shock;
- on the basis of the treatment of total vasoactive drugs dose > 0.2 μg/kg/min norepinephrine (or equivalent dose of another vasoactive drug: such as epinephrine > 0.2 μg/kg/min, dopamine > 30 μg/kg/min, phenylephrine > 2 μg/kg/min, vasopressin > 0.08 U/min) and continuous treatment for at least 6 hours and no more than 48 hours, the patient's mean arterial pressure can still only be maintained between 55 and 70 mmHg, or do not reach the target MAP assessed by clinicians, it can be diagnosed as refractory distributive shock.
- have central venous access and arterial catheters, and are expected to be present for at least the first 48 hours of the study.
- indwelling catheter, and expected to be present for at least the first 48 hours of the study.
- patient has received at least 30 mL/kg of crystalloid or colloid volume in the previous 24 hours or has undergone adequate volume resuscitation in the opinion of the investigator.
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- patients must have one of the following criteria with clinical features of high-output shock
- Central venous oxygen saturation (ScVO2) > 70% (via saturation catheter or central venous blood gas) and central venous pressure (CVP) > 8 mmHg.
- cardiac index (CI) > 2.3 L/min/m2.
- the patient or legal representative is willing and able to provide written informed consent and comply with all protocol requirements.
Who cannot join
- Patients with burns > 20% of total body surface area;
- Patients with cardiovascular (CV) SOFA score ≤ 3;
- Patients with acute coronary syndrome requiring interventional therapy;
- Patients treated with Extracorporeal Membrane Oxygenation (ECMO);
- Patients with end-stage liver failure (Model for end-stage liver disease score (MELD) > 30).
- Patients with a diagnosis of asthma or bronchospasm.
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- Patients with a diagnosis of acute mesenteric ischemia, or patients with suspected acute mesenteric ischemia.
- Patients with a history, presence, or high suspicion of aortic dissection or abdominal aortic aneurysm, or patients diagnosed with aortic dissection or abdominal aortic aneurysm.
- Patients who have been diagnosed with malignant tumor within the past 2 years, except for early malignant tumors (carcinoma in situ or stage I tumor) that have been radically treated or expected to recover after treatment, such as adequately treated thyroid cancer, cervical carcinoma in situ, basal cell or squamous cell carcinoma.
- Patients with Raynaud's phenomenon, systemic sclerosis or vasospastic disease.
- Patients with life expectancy ≤ 24 hours as assessed by the study physician.
- Patients with active bleeding who are expected to require transfusion of > 4 units of packed red blood cells within 48 hours of study start.
- Patients with active bleeding and hemoglobin < 7 g/dL or any other condition that contraindicates serial blood sampling.
- Patients with absolute neutrophil count (ANC) < 1000 cells/mm3.
- Patients with known hypersensitivity to angiotensin II injection and its excipients.
- Patients who are currently participating in another interventional clinical trial.
- Blood/urine pregnancy test should be performed for patients with known pregnancy at screening and those with clinical suspicion of pregnancy.
- Patients who are considered unstable by the investigator or have any condition that would affect the safety of the study or the interpretation of the study results, or that would prevent the patient from completing the study, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical disorders. For example: patients with arrhythmia, uncontrolled hyperglycemia, cerebrovascular disease, uncontrolled hypertension, autoimmune disease requiring daily use of ≥ 500 mg hydrocortisone or equivalent glucocorticoids, etc.
Trial locations and contacts
42 sites in 1 country. Contact the study team or a site near you to ask about taking part.
42 sites in 1 country
China42 sites, 42 recruiting
- Not yet recruiting
The Affiliated Hospital of Hebei University
Baoding, Hebei, 050031
Zhanbiao Yu, M.D., 15188655821, daxiang285@sina.com
- Not yet recruiting
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100070
Guangzhi Shi, Doctor, 13241078866, zjfyanger@sina.com
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yun Long, M.D., 13911608699, yunlongxh@163.com
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Henan, 233099
Yongsheng Zheng, M.D., 13955252796, zsy0916@163.com
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 140008
Lina Zhang, M.D., 15874875763, zln7095@163.com
- Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410001
Xu Zhou, Doctor, 13907319339, zhouxumd@163.com
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Yan Kang, M.D., 13808041931, kangyan_hx@163.com
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Xiaobo Huang, M.D., 18140049936, drhuangxb@163.com
- Not yet recruiting
The Frist Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Xiaoli Han, Doctor, 13271943396, hxl093@163.com
- Not yet recruiting
The people's Hospital of the University of traditional Chinese medicine in Fujian
Fuzhou, Fujian, 350108
Hongyan Li, Doctor, 13850153821, 1353626039@qq.com
- Not yet recruiting
The First Affiliated Hospital of Sun Yat sen University
Guangzhou, Guangdong, 510062
Xiangdong Guan, M.D., 13802925067, guanxiangdong1962@163.com
- Not yet recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510260
Zhanguo Liu, M.D., 18520711669, zhguoliu@163.com
- Not yet recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510632
Haiyan Yin, Doctor, 13318831222, yinhaiyan1867@126.com
- Not yet recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, 543300
Lin Han, Doctor, 1367719170, xhan0507@sina.com
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Feng Shen, Doctor, 13511999117, doctorshenfeng@163.com
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150007
Mingyan Zhao, M.D., 13796118989, mingyan0927@126.com
- Not yet recruiting
The Second People's Hospital of Hefei
Hefei, Anhui, 230011
Li Yao, Doctor, 13956061055, ylirn168@163.com
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Chen Li, Doctor, 18560081005, intensive-1@163.com
- Not yet recruiting
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
Dongquan Zhang, Doctor, 13919284411, gostwarrior@163.com
- Not yet recruiting
Liuzhou General Hospital
Liuzhou, Guangxi, 545026
Guangyu Lv, M.D., 13977210130, lgy197823@163.com
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 450052
Qizhi Fu, M.D., 13837944687, fuqizhi33@sina.com
- Not yet recruiting
The Frist Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Fen Liu, Doctor, 13870603218, 452848077@qq.com
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Quan Cao, M.D., 13851992695, 2004caoquan@163.com
- Not yet recruiting
The Frist Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020
Jihui Ye, Doctor, 15867571821, 709213065@qq.com
- Not yet recruiting
Qingyuan Hospital Affiliated to Guangzhou Medical University
Qingyuan, Guangdong, 511518
Jingwen Yang, M.D., 13542498765, 00655@qyry.com
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Ruilan Wang, Doctor, 13917138008, wangyusun@hotmail.com
- Not yet recruiting
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Yongru Chen, M.D., 13411969797, ongruchen@126.com
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Bin Zang, Doctor, 18940251116, zangbin66@aliyun.com
- Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Lei Huang, Doctor, 13510331883, hl0248@outlook.com
- Not yet recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Jing Cao, M.D., 13834691242, 13834691242@163.com
- Not yet recruiting
Taizhou hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
Yinghe Xu, Doctor, 13706763731, 13706763731@163.com
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Yanfen Chai, Doctor, 13821582860, chaiyanfen2012@126.com
- Not yet recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300190
Hongmei Gao, Doctor, 1307225 6661, ghm182@163.com
- Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Xiangyou Yu, M.D., 13009681003, yu2796@163.com
- Not yet recruiting
Union Hospital, Tongji Medical College of huazhong university of science and technology
Wuhan, Hubei, 430022
You Shang, M.D., 15972127819, you_shanghust@163.com
- Not yet recruiting
Wuhan Third Hospital
Wuhan, Hubei, 430060
Shouzhi Fu, Doctor, 18186118296, fszfsz188@163.com
- Not yet recruiting
The Frist Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001
Weihua Lu, Doctor, 13955370637, Lwh683@126.com
- Not yet recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
Hongyang Xu, Doctor, 13358110913, 940216583@qq.com
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
Xiaochuang Wang, M.D., 13772152935, 1585431074@qq.com
- Not yet recruiting
The Frist Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710048
Qindong Shi, Doctor, 18991232391, shiqindong@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Tongwen Sun, M.D., 13838516916, suntongwen@163.com
- Not yet recruiting
Zibo Central Hospital
Zibo, Shandong, 255020
Weiwei Song, Doctor, 18678186873, maomaochong1226@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Angiotensin II Injection in the Background Treatment of Catecholamines and Other Vasopressors in Chinese Adult Patients With Refractory Distributive Shock
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
- Being tested
- Angiotensin II Injection, 0.9% sodium chloride injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin II InjectionDrug
1、Angiotensin II injection is a naturally occurring octapeptide hormone in the human renin angiotensin aldosterone system (RAAS). It is the main effector molecule of the RAAS system and one of the strongest known vasoconstrictors, involved in neurohumoral regulation.
0.9% sodium chloride injectionDrug
0.9% sodium chloride injection, not containing active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Angiotensin Ⅱ Injection | Experimental | Angiotensin II injection is administered via central vein, and the drug dosage is adjusted according to Mean Arterial Pressure (MAP), with an allowable dose of 1.25~160 ng/kg/min. Maximum 168 h. Receives: Drug: Angiotensin II Injection |
| Placebo | Placebo comparator | The placebo is administered via central vein, and the drug dosage is adjusted according to MAP, with an allowable dose of 1.25~160 ng/kg/min. Maximum 168 h. Receives: Drug: 0.9% sodium chloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with blood pressure response at 3 hours after administration of study drug
Defined as MAP ≥ 75 mmHg or MAP increase ≥ 10 mmHg from baseline compared to baseline without an increase in the dose of background vasoactive agents
Measured: 3 hours after dose
Secondary outcomes (13)
Sequential Organ Failure Assessment (SOFA) total score
Change from baseline in Sequential Organ Failure Assessment (SOFA) total score. The SOFA score evaluates organ failure according to the conditions of respiratory, blood, liver, cardiovascular, central nervous, kidney and other systems, is scored from 0 to 4, with a higher score representing more severe failure.
Measured: 48 hours after dose
Cardiovascular SOFA subscore
Change from baseline in Sequential Organ Failure Assessment (SOFA) subscore. The SOFA score evaluates organ failure according to the conditions of respiratory, blood, liver, cardiovascular, central nervous, kidney and other systems, is scored from 0 to 4, with a higher score representing more severe failure.
Measured: 48 hours after dose
Mortality at Day 7
All-cause mortality of subject at Day 7
Measured: Day 7 after dose
Mortality at Day 28
All-cause mortality of subject at Day 28
Measured: Day 28 after dose
Proportion of subjects with blood pressure response at 1 hour after administration
Defined as MAP ≥ 75 mmHg or MAP increase ≥ 10 mmHg from baseline compared to baseline without an increase in the dose of background vasoactive agents
Measured: 1 hour after dose
Proportion of subjects with blood pressure response at 2 hours after administration
Defined as MAP ≥ 75 mmHg or MAP increase ≥ 10 mmHg from baseline compared to baseline without an increase in the dose of background vasoactive agents
Measured: 2 hours after dose
Change in background vasoactive agent dose from 0 to 48 hours
Change in background vasoactive dose from baseline to 48 hours after dose
Measured: 48 hours after dose
Absolute change in blood lactate from 0 to 3 hours
Absolute change in blood lactate from 0 to 3 hours
Measured: 3 hours after dose
Absolute change in blood lactate from 3 to 48 hours
Absolute change in blood lactate from 3 to 48 hours
Measured: 3 to 48 hours after dose
Absolute change in heart rate from 0 to 3 hours
Absolute change in heart rate from 0 to 3 hours
Measured: 3 hours after dose
Absolute change in heart rate from 3 to 48 hours
Absolute change in heart rate from 3 to 48 hours
Measured: 3 to 48 hours after dose
Adverse events (AE)
Incidence and severity of adverse events (AE)
Measured: From drug administration to the end of the study, a total of 28 days
Serious adverse events (SAE)
Incidence and severity of serious adverse events (SAE)
Measured: From drug administration to the end of the study, a total of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start23 Jul 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasodilatory ShockStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351150
- Sponsor's protocol ID
- TQG3902-III-01
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No