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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
214
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 injection, not containing active ingredients.
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
Time frame: 3 hours after dose
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.
Time frame: 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.
Time frame: 48 hours after dose
Mortality at Day 7
All-cause mortality of subject at Day 7
Time frame: Day 7 after dose
Mortality at Day 28
All-cause mortality of subject at Day 28
Time frame: 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
Time frame: 1 hour after dose
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The Second People's Hospital of Hefei
Hefei, Anhui, China
NOT_YET_RECRUITINGThe Frist Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
NOT_YET_RECRUITINGBeijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe Frist Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe people's Hospital of the University of traditional Chinese medicine in Fujian
Fuzhou, Fujian, China
NOT_YET_RECRUITINGGansu Provincial Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Sun Yat sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGZhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
NOT_YET_RECRUITING...and 32 more locations
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
Time frame: 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
Time frame: 48 hours after dose
Absolute change in blood lactate from 0 to 3 hours
Absolute change in blood lactate from 0 to 3 hours
Time frame: 3 hours after dose
Absolute change in blood lactate from 3 to 48 hours
Absolute change in blood lactate from 3 to 48 hours
Time frame: 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
Time frame: 3 hours after dose
Absolute change in heart rate from 3 to 48 hours
Absolute change in heart rate from 3 to 48 hours
Time frame: 3 to 48 hours after dose
Adverse events (AE)
Incidence and severity of adverse events (AE)
Time frame: 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)
Time frame: From drug administration to the end of the study, a total of 28 days