Background
Methods/design
Research type
Study setting
Research setting | Ethics committee name | Approval registration number |
---|---|---|
Zhongshan Hospital, Fudan University | Medical ethics committee of Zhongshan Hospital, Fudan University | 2011-(38)3 |
Second Military Medical University, Changhai Hospital | Medical ethics committee of Second Military Medical University, Changhai Hospital | CHEC2013-107 |
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Medical ethics committee of First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | SLK2012012-1 |
Tianjin Medical University General Hospital | Drug ethics committee of Tianjin Medical University General Hospital | IRB2013-021-02 |
People’s Liberation Army General Hospital of Shenyang Military Region | Medical ethics committee of People’s Liberation Army General Hospital of Shenyang Military Region | k2013-02 |
First Affiliated Hospital of Dalian Medical University | Ethics committee of First Affiliated Hospital of Dalian Medical University | LCSY2014-02 |
Second Affiliated Hospital of Harbin Medical University | Medical ethics committee of Second Affiliated Hospital of Harbin Medical University | 2013-研-012 |
Chinese People’s Liberation Army General Hospital | Medical ethics committee of Chinese People’s Liberation Army General Hospital | C2014-001-01 |
First Affiliated Hospital of Chinese People’s Liberation Army General Hospital | Medical ethics committee of First Affiliated Hospital of Chinese People’s Liberation Army General Hospital | C2014-001-01 |
Qilu Hospital of Shandong University | National drug clinical trial ethics committee of Qilu Hospital of Shandong University | 2013068(1) |
Second Affiliated Hospital of Hebei Medical University | Medical ethics committee of Second Affiliated Hospital of Hebei Medical University | 2013EC10-01-1 |
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences | Ethical review committee of Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences | S-519 |
People’s Liberation Army Air Force General Hospital | Ethics committee of People’s Liberation Army Air Force General Hospital | 空总药字第2013-04 |
People’s Liberation Army Second Artillery General Hospital | Ethics committee of People’s Liberation Army Second Artillery General Hospital | 2013013 |
People’s Hospital of Wuhan University | Medical ethics committee of People’s Hospital of Wuhan University | [2013]伦审字(066)号 |
Zhongnan Hospital of Wuhan University | Medical ethics committee of Zhongnan Hospital of Wuhan University | (2013)伦审字(024)号 |
Wuhan General Hospital of Guangzhou Military Region, People’s Liberation Army | Medical ethics committee of Wuhan General Hospital of Guangzhou Military Region, People’s Liberation Army | [2013]005-2号 |
The First Hospital of Jilin University | Ethics committee of The First Hospital of Jilin University | (2014)临审第(140512-049)号 |
Xin Hua Hospital affiliated with Shanghai Jiaotong University School of Medicine | Medical ethics committee of Xin Hua Hospital affiliated with Shanghai Jiaotong University School of Medicine | XHEC-A-2013-041-2 |
People’s Liberation Army Guangzhou Military General Hospital | Institutional review board for clinical trials of People’s Liberation Army Guangzhou Military General Hospital | 批件(2014)-0014 |
West China Hospital of Sichuan University | Clinical test and biomedical ethics branch of West China Hospital of Sichuan University | 2013年临床试验(上市)审(14)号 |
Hunan Provincial People’s Hospital | Medical ethics committee of Hunan Provincial People’s Hospital | [2015]-06 |
Beijing Millennium Monument Hospital | Medical ethics committee of Beijing Millennium Monument Hospital | (2013)伦审第(57)号 |
People’s Liberation Army Beijing Military General Hospital | Institutional review board for clinical trials of People’s Liberation Army Beijing Military General Hospital | BZEC2013-063 |
Shiyan Taihe Hospital | Drug clinical trials ethics committee of Shiyan Taihe Hospital | 2015第(01)号 |
Yuhuangding Hospital Affiliated with Qingdao University | Ethics committee of Yuhuangding Hospital Affiliated with Qingdao University | 烟毓医伦理审[2014]32号 |
Guangdong Province Chinese Medicine Hospital | Ethics committee of Guangdong Province Chinese Medicine Hospital | 广东省中医院伦理委员会B2013-165-01 |
First Affiliated Hospital of Fourth Military Medical University | Drug clinical trials ethics committee of First Affiliated Hospital of Fourth Military Medical University | KY20140813-3 |
The First Affiliated Hospital of Anhui Medical University | Clinical trial ethics committee of The First Affiliated Hospital of Anhui Medical University | 安医一附院伦审-PJ2015-02-07 |
The Fourth Affiliated Hospital of China Medical University | Medical ethics committee of The Fourth Affiliated Hospital of China Medical University | 2015-020 |
Study criteria
Diagnostic criteria
Inclusion criteria
Exclusion criteria
Other criteria
Interventions
Methods of administration
Routine medications for SP
Dispensing and combination methods
Precautions
Sample size
Randomization
Blinding
Blinding methods
Emergency unblinding
Content and points of data capture
Content | Screening | Intervention | After intervention | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 | Visit 8 | Visit 9 | Visit 10 | |
Day | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 28 |
Informed consent form | Χ | |||||||||
Pregnancy test | Χ | |||||||||
Demographic information | Χ | |||||||||
Inclusion/exclusion criteria | Χ | |||||||||
Get SSID and random number | Χ | |||||||||
History of SP and treatment | Χ | |||||||||
History of medication and treatment | Χ | |||||||||
Concomitant diseases | Χ | |||||||||
Complications | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |
Body weight and body mass index | Χ | Χ | ||||||||
Vital signs | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |
Laboratory tests | Χ | Χ | Χ | |||||||
Safety outcomes | Χ | Χ | Χ | Χ | ||||||
Mean arterial pressure | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |
Central venous pressure | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |
Blood gas analysis | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |
Mechanical ventilation parameters | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |
Chest x-ray or CT scan | Χ | Χ | Χ | |||||||
Sputum and blood culture | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |
Record of routine treatment | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |||
Issue study drug | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |||
Record issue and recovery drug | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |||
Record adverse events | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |||
Severity-of-illness scores | Χ | Χ | Χ | |||||||
Stage efficacy evaluation | Χ | Χ | ||||||||
Length of mechanical ventilation | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |
Length of stay in ICU | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |
Length of hospitalization | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |
Length of antibiotic use | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | |
Efficacy and safety evaluation | Χ | |||||||||
Main treatment affecting prognosis | Χ | |||||||||
Survival follow-up | Χ |
Outcome measures
Primary outcome measures
Secondary outcome measures
Total score of four items | Total scores for the three items (except lung compliance) | |||
---|---|---|---|---|
Decrease ≥4 | Decrease 2–3 | Decrease 1 | No change or increase | |
Decrease ≥6 | Significantly effective | Significantly effective | Significantly effective | Significantly effective |
Decrease 4–5 | Significantly effective | Moderately effective | Slightly effective | Slightly effective |
Decrease 2–3 | Slightly effective | Slightly effective | Slightly effective | Slightly effective |
No change or increase | Ineffective | Ineffective | Ineffective | Ineffective |