Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS) A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 10
- 主要终点
- The incidence of ARDS
研究概览
简要总结
Since strategies were applied in intensive care medicine, including low tidal volume ventilation, fluid resuscitation, use of antibiotics, restrictive transfusion strategy and bundle of ventilator therapy, the incidence of Acute Respiratory Distress Syndrome (ARDS) has been decreased recent years. However, the mortality of severe ARDS is still higher to 45%. Few medications did were indicated to be effective in working on development of ARDS. Different with other disease, ARDS were difficult to prevent in its later stage like a domino effect. The medication interventions are all used after ARDS was developed, including ulinastatin. The investigators hypothesized that the key point in failure of medication therapy is the delay timing of medication intervention. If given the preventive strategy, such as ulinastatin, the incidence or the severity of ARDS might be decreased. Therefore this is a randomized controlled trial to test the hypothesis of the preventive effect of ulinastatin in ARDS.
This is a multi-center, randomized, double blinded, placebo controlled study.
详细描述
Since strategies were applied in intensive care medicine, including low tidal volume ventilation, fluid resuscitation, use of antibiotics, restrictive transfusion strategy and bundle of ventilator therapy, the incidence of Acute Respiratory Distress Syndrome (ARDS) has been decreased recent years. However, the mortality of severe ARDS is still higher to 45%. Few medications did were indicated to be effective in working on development of ARDS. Different with other disease, ARDS were difficult to prevent in its later stage like a domino effect. The medication interventions are all used after ARDS was developed, including ulinastatin. The investigators hypothesized that the key point in failure of medication therapy is the delay timing of medication intervention. If given the preventive strategy, such as ulinastatin, the incidence or the severity of ARDS might be decreased.
Ulinastatin is a urinary trypsin inhibitor (UTI) that inhibits various inflammatory proteases has been widely used in China, Japan, and Korea for the treatment of patients with inflammatory disorders, postoperative organs protection, shock, and pancreatitis.
Therefore this is a randomized controlled trial to test the hypothesis of the preventive effect of ulinastatin in ARDS.
This is a multi-center, randomized, double blinded, placebo controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should be more than 18 years old
- •Patients are expected to living within 72 hours of ICU admission
- •Patients' Lung Injury Prediction Score (LIPS) more than 4 and got at least 1 risk factors as below: bacteremia, sepsis or sepsis shock, pneumonia, multiple fractures, pulmonary contusion, aspiration, multiple blood transfusion, severe acute pancreatitis.
排除标准
- •Patients will be excluded when they are
- •diagnosed as ARDS
- •without written informed consent
- •with HIV infection
- •with other immunologic deficiency (leukaemia, immune deficiency syndrome, etc)
- •with organ transplantation or bone marrow transplantation
- •with chronic pulmonary disease (except for Chronic Obstructive Pulmonary Disease (COPD) or asthma)
- •with angitis
- •with neutropenia (except for secondary to sepsis)
- •using granulocyte-macrophage colony-stimulating factor or granulocyte colony-stimulating factor
- •using asprin or clopidogrel
- •using glucocorticoid
- •withdrawing treatment
- •treated by Xuebijing, thymosin, or intravenous immunoglobulin 1 month before enrollment
- •enrolled in other clinical trials 3 months before enrollment
- •being pregnancy
- •being lactation
研究组 & 干预措施
Ulinastatin group
200,000 IU ulinastatin will be dissolved in 100 mL of 0.9% normal saline by continuous intravenous infusion for 1h, 3 times per day for 5 days.
干预措施: Ulinastatin (Drug)
Ulinastatin group
200,000 IU ulinastatin will be dissolved in 100 mL of 0.9% normal saline by continuous intravenous infusion for 1h, 3 times per day for 5 days.
干预措施: Usual care (Other)
Control group
Control group will be in usual care without any intervention.
干预措施: Usual care (Other)
结局指标
主要结局
The incidence of ARDS
时间窗: 3 years
次要结局
- Total cost in admission(3 years)
- Adverse events related to drugs.(3 years)
- The numbers of ARDS patients who meet the criteria for mild, moderate, and severe using the Berlin Definition, separately.(3 years)
- The number of patients who need mechanical ventilation(3 years)
- Lengths of ICU(3 years)
- The incidence of other organ disorders(3 years)
- Mortality of 28 days(0-28 days)
- Lengths of mechanical ventilation(3 years)
- Lengths of stay(3 years)
- Mortality of 60 days(0-60 days)
研究者
Zhu Xi
M.D. Chief physician
Peking University Third Hospital