Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiotensin II Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 hours after dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours after dose |
Not provided
Inclusion Criteria:
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.
patients must have one of the following criteria with clinical features of high-output shock
the patient or legal representative is willing and able to provide written informed consent and comply with all protocol requirements.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangdong Guan, M.D. | Contact | 13802925067 | guanxiangdong1962@163.com | |
| Yan Kang, M.D. | Contact | 13808041931 | kangyan_hx@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Hefei | Not yet recruiting | Hefei | Anhui | 230011 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 0.9% sodium chloride injection | Drug | 0.9% sodium chloride injection, not containing active ingredients. |
|
| 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. | 48 hours after dose |
| Mortality at Day 7 | All-cause mortality of subject at Day 7 | Day 7 after dose |
| Mortality at Day 28 | All-cause mortality of subject at Day 28 | 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 | 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 | 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 | 48 hours after dose |
| Absolute change in blood lactate from 0 to 3 hours | Absolute change in blood lactate from 0 to 3 hours | 3 hours after dose |
| Absolute change in blood lactate from 3 to 48 hours | Absolute change in blood lactate from 3 to 48 hours | 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 | 3 hours after dose |
| Absolute change in heart rate from 3 to 48 hours | Absolute change in heart rate from 3 to 48 hours | 3 to 48 hours after dose |
| Adverse events (AE) | Incidence and severity of adverse events (AE) | 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) | From drug administration to the end of the study, a total of 28 days |
| The Frist Affiliated Hospital of Wannan Medical College | Not yet recruiting | Wuhu | Anhui | 241001 | China |
|
| Beijing Tiantan Hospital,Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100070 | China |
|
| Peking Union Medical College Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100730 | China |
|
| The Frist Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400010 | China |
|
| The people's Hospital of the University of traditional Chinese medicine in Fujian | Not yet recruiting | Fuzhou | Fujian | 350108 | China |
|
| Gansu Provincial Hospital | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
|
| The First Affiliated Hospital of Sun Yat sen University | Not yet recruiting | Guangzhou | Guangdong | 510062 | China |
|
| Zhujiang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | 510260 | China |
|
| The First Affiliated Hospital of Jinan University | Not yet recruiting | Guangzhou | Guangdong | 510632 | China |
|
| Qingyuan Hospital Affiliated to Guangzhou Medical University | Not yet recruiting | Qingyuan | Guangdong | 511518 | China |
|
| The First Affiliated Hospital of Shantou University Medical College | Not yet recruiting | Shantou | Guangdong | 515041 | China |
|
| Peking University Shenzhen Hospital | Not yet recruiting | Shenzhen | Guangdong | 518036 | China |
|
| The People's Hospital of Guangxi Zhuang Autonomous Region | Not yet recruiting | Guilin | Guangxi | 543300 | China |
|
| Liuzhou General Hospital | Not yet recruiting | Liuzhou | Guangxi | 545026 | China |
|
| The Affiliated Hospital of Guizhou Medical University | Not yet recruiting | Guiyang | Guizhou | 550004 | China |
|
| The Affiliated Hospital of Hebei University | Not yet recruiting | Baoding | Hebei | 050031 | China |
|
| The First Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | 150007 | China |
|
| The First Affiliated Hospital of Bengbu Medical College | Not yet recruiting | Bengbu | Henan | 233099 | China |
|
| The First Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | Luoyang | Henan | 450052 | China |
|
| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
|
| Union Hospital, Tongji Medical College of huazhong university of science and technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
|
| Wuhan Third Hospital | Not yet recruiting | Wuhan | Hubei | 430060 | China |
|
| Xiangya Hospital Central South University | Not yet recruiting | Changsha | Hunan | 140008 | China |
|
| Hunan Provincial People's Hospital | Not yet recruiting | Changsha | Hunan | 410001 | China |
|
| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
|
| Wuxi People's Hospital | Not yet recruiting | Wuxi | Jiangsu | 214023 | China |
|
| The Frist Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
|
| Shengjing Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110004 | China |
|
| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710004 | China |
|
| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 250000 | China |
|
| Zibo Central Hospital | Not yet recruiting | Zibo | Shandong | 255020 | China |
|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
|
| The First Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | 030001 | China |
|
| The Frist Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi’an | Shanxi | 710048 | China |
|
| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610044 | China |
|
| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610072 | China |
|
| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300052 | China |
|
| Tianjin First Central Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300190 | China |
|
| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | 830054 | China |
|
| The Frist Affiliated Hospital of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | 315020 | China |
|
| Taizhou hospital of Zhejiang Province | Not yet recruiting | Taizhou | Zhejiang | 317000 | China |
|
| ID | Term |
|---|---|
| D000804 | Angiotensin II |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000809 | Angiotensins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided