The Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
- Registration Number
- NCT02895191
- Lead Sponsor
- Techpool Bio-Pharma Co., Ltd.
- Brief Summary
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.
- Detailed Description
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．
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Have provided signed written informed consent form (ICF) from the patient or the patient's legal representative;
- Male or Female patients ≥18 years of age;
- ARDS defined with using 2012 Berlin Criteria;
- ARDS diagnosed ≤7 days, and patients should be mechanically ventilated(invasive and or noninvasive mechanical ventilation); 5)100mmhg < PaO2/FiO2 < 250mmhg with CPAP/PEEP≥5 cmH2O;
- Patient with known hypersensitivity to Ulinastatin/adjuvant or patient with allergic constitution;
- Patients with artificial organs replacement therapy for liver or kidney；
- Glasgow Coma Scale (GCS)≤8；
- Cardiogenic pulmonary edema , and the cardiogenic pulmonary edema is as the only or primary reason for respiratory failure;
- ARDS caused by burning, drowning, poisoning;
- Presence of severe chronic liver diseases (Child-Pugh score 12-15)，or severe chronic respiratory disease with a PaCO2 > 50 mmHg or the use of home oxygen;
- Neutrophils<1.5×10^9/L
- Moribund patients (i.e.,expected to live no longer than 24 hours) or with recent (within 7days or anytime during present hospitalization) cardiopulmonary arrest;
- Patients need long-term glucocorticoid treatment or need to be treated with immunosuppressive drugs;
- No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol;
- Lung transplant patients;
- Patients with malignancy, expected to live no longer than 6 months;
- Pregnant or breast-feeding;
- Patients who have participated in any clinical study within 3 months prior to the screening;
- Any condition that in the opinion of the investigator would add the patient's risk or jeopardize the operation of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 ulinastatin Cohort 3- Ulinastatin 1.2 million units per day control group placebo Placebo Cohort 1 ulinastatin Cohort 1- Ulinastatin 4.8 million units per day Cohort 2 ulinastatin Cohort 2- Ulinastatin 2.4 million units per day
- Primary Outcome Measures
Name Time Method The incidence of adverse events(AEs) which can not excluded relatedness with study Product Day 1 to Day 90
- Secondary Outcome Measures
Name Time Method Days alive and off ventilator Day 1 to Day 28 Days in the ICU Day 1 to Day 14 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 Changes of PaO2/FiO2 ratio Day 0 and Day 1 to within 24h after the last treatment 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
Trial Locations
- Locations (11)
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
Huadong Hospital,Fudan University
🇨🇳Shanghai, Shanghai, China
First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghia, China
West China Hospital,Sichuan Unversity
🇨🇳Chengdu, Sichuan, China
Zhejiang Hospital
🇨🇳Hangzhou, Zhejiang, China
Lishui City People's Hospital
🇨🇳Lishui, Zhejiang, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China