Actively Recruiting
Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-01-23
214
Participants Needed
42
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Diagnosis of distributive shock
- Receiving total vasoactive drug dose greater than 0.2 mcg/kg/min norepinephrine (or equivalent) continuously for at least 6 hours and no more than 48 hours
- Mean arterial pressure maintained only between 55 and 70 mmHg or below target despite treatment
- Presence of central venous access and arterial catheters expected for at least 48 hours
- Received at least 30 mL/kg of crystalloid or colloid fluids in the previous 24 hours or judged adequately volume resuscitated
- Clinical features of high-output shock: either central venous oxygen saturation over 70% with central venous pressure over 8 mmHg, or cardiac index over 2.3 L/min/m2
- Patient or legal representative able and willing to provide written informed consent and comply with protocol
You will not qualify if you...
- Burns covering more than 20% of total body surface area
- Cardiovascular SOFA score less than or equal to 3
- Acute coronary syndrome requiring interventional therapy
- Treatment with Extracorporeal Membrane Oxygenation (ECMO)
- End-stage liver failure (MELD score over 30)
- Diagnosis of asthma or bronchospasm
- Acute or suspected acute mesenteric ischemia
- History or suspicion of aortic dissection or abdominal aortic aneurysm
- Malignant tumor diagnosed within past 2 years except early stage tumors treated or expected to recover
- Raynaud's phenomenon, systemic sclerosis, or vasospastic disease
- Life expectancy 24 hours or less
- Active bleeding likely to require transfusion of more than 4 units of red blood cells within 48 hours
- Active bleeding with hemoglobin less than 7 g/dL or contraindications to serial blood sampling
- Absolute neutrophil count less than 1000 cells/mm3
- Known hypersensitivity to angiotensin II injection or excipients
- Current participation in another interventional clinical trial
- Pregnancy or suspected pregnancy without negative test
- Unstable condition or any major physical or psychiatric disorders affecting safety or study completion
AI-Screening
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Trial Site Locations
Total: 42 locations
1
The Second People's Hospital of Hefei
Hefei, Anhui, China, 230011
Not Yet Recruiting
2
The Frist Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China, 241001
Not Yet Recruiting
3
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100070
Not Yet Recruiting
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
5
The Frist Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Not Yet Recruiting
6
The people's Hospital of the University of traditional Chinese medicine in Fujian
Fuzhou, Fujian, China, 350108
Not Yet Recruiting
7
Gansu Provincial Hospital
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
8
The First Affiliated Hospital of Sun Yat sen University
Guangzhou, Guangdong, China, 510062
Not Yet Recruiting
9
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510260
Not Yet Recruiting
10
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510632
Not Yet Recruiting
11
Qingyuan Hospital Affiliated to Guangzhou Medical University
Qingyuan, Guangdong, China, 511518
Not Yet Recruiting
12
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515041
Not Yet Recruiting
13
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Not Yet Recruiting
14
The People's Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, China, 543300
Not Yet Recruiting
15
Liuzhou General Hospital
Liuzhou, Guangxi, China, 545026
Not Yet Recruiting
16
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Not Yet Recruiting
17
The Affiliated Hospital of Hebei University
Baoding, Hebei, China, 050031
Not Yet Recruiting
18
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150007
Not Yet Recruiting
19
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Henan, China, 233099
Not Yet Recruiting
20
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 450052
Not Yet Recruiting
21
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
22
Union Hospital, Tongji Medical College of huazhong university of science and technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
23
Wuhan Third Hospital
Wuhan, Hubei, China, 430060
Not Yet Recruiting
24
Xiangya Hospital Central South University
Changsha, Hunan, China, 140008
Not Yet Recruiting
25
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410001
Not Yet Recruiting
26
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
27
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214023
Not Yet Recruiting
28
The Frist Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
29
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
30
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710004
Not Yet Recruiting
31
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250000
Not Yet Recruiting
32
Zibo Central Hospital
Zibo, Shandong, China, 255020
Not Yet Recruiting
33
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
34
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Not Yet Recruiting
35
The Frist Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710048
Not Yet Recruiting
36
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610044
Not Yet Recruiting
37
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
38
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Not Yet Recruiting
39
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China, 300190
Not Yet Recruiting
40
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830054
Not Yet Recruiting
41
The Frist Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315020
Not Yet Recruiting
42
Taizhou hospital of Zhejiang Province
Taizhou, Zhejiang, China, 317000
Not Yet Recruiting
Research Team
X
Xiangdong Guan, M.D.
CONTACT
Y
Yan Kang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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