NCT02895191Unknown2 期
A Randomized, Blind, Placebo-controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 11
- 主要终点
- The incidence of adverse events(AEs) which can not excluded relatedness with study Product
研究概览
简要总结
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.
详细描述
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．
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
control group
Placebo Comparator
Placebo
干预措施: placebo (Drug)
Cohort 2
Experimental
Cohort 2- Ulinastatin 2.4 million units per day
干预措施: ulinastatin (Drug)
Cohort 3
Experimental
Cohort 3- Ulinastatin 1.2 million units per day
干预措施: ulinastatin (Drug)
Cohort 1
Experimental
Cohort 1- Ulinastatin 4.8 million units per day
干预措施: ulinastatin (Drug)
结局指标
主要结局
The incidence of adverse events(AEs) which can not excluded relatedness with study Product
时间窗: Day 1 to Day 90
次要结局
- 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)
研究者
研究点 (11)
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