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| Name | Class |
|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
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Compared with placebo, evaluate the effects and safety of Ulinastatin(UTI) added to conventional treatment for ARDS; Evaluate the dose response relationship of Ulinastatin for ARDS.
After signed off the informed consent form by patient or surrogate, and after completing the screening phase, the patients who fulfill the inclusion and exclusion criteria will be randomized 1:1:1:1 to the 4 study arms. All the Patients will receive the study treatment drugs for 7 to 14 days. Use Day 28 of last patient as a cut-off day, Collect the follow up visit data on both Day 28 and Day 90 of other patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Cohort 1- Ulinastatin 4.8 million units per day |
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| Cohort 2 | Experimental | Cohort 2- Ulinastatin 2.4 million units per day |
|
| Cohort 3 | Experimental | Cohort 3- Ulinastatin 1.2 million units per day |
|
| control group | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ulinastatin | Drug | Patients will receive the study drugs for 7 to 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events(AEs) which can not excluded relatedness with study Product | Day 1 to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of PaO2/FiO2 ratio | Day 0 and Day 1 to within 24h after the last treatment | |
| Days alive and off ventilator | Day 1 to Day 28 | |
| Days in the ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yimin Li, Doctor | First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China | ||
| Beijing Anzhen Hospital, Capital Medical University |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| C028665 | urinastatin |
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| placebo | Drug | Patients will receive the placebo for 7 to 14 days |
|
| Day 1 to Day 14 |
| Changes of pulmonary compliance | Day 1 , Day 3 ,Day7 and within 24h after the last treatment |
| Rate of new organ failure | Day 1 to Day 90 |
| Changes of APACHEⅡ Score from baseline | Day 3 ,Day7 and within 24h after the last treatment |
| Changes of Murray Lung Injury Score from baseline | Day 3 ,Day7 and within 24h after the last treatment |
| Changes of Sequential Organ Failure Assessment (SOFA) score from baseline | Day 3 ,Day7 and within 24h after the last treatment |
| All-cause mortality | Day 28 , Day 90 and Day 1 to Day 14 |
| Beijing |
| Beijing Municipality |
| 100029 |
| China |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | 510180 | China |
| First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| Hainan General Hospital | Haikou | Hainan | 570311 | China |
| Huadong Hospital,Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghia | 200233 | China |
| West China Hospital,Sichuan Unversity | Chengdu | Sichuan | 610041 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830054 | China |
| Zhejiang Hospital | Hangzhou | Zhejiang | 310030 | China |
| Lishui City People's Hospital | Lishui | Zhejiang | 323000 | China |