Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS)
- Conditions
- Acute Respiratory Distress SyndromeCritical Illness
- Interventions
- Other: Usual care
- Registration Number
- NCT03089957
- Lead Sponsor
- Peking University Third Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 840
- 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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ulinastatin group Usual care 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. Control group Usual care Control group will be in usual care without any intervention. Ulinastatin group Ulinastatin 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.
- Primary Outcome Measures
Name Time Method The incidence of ARDS 3 years
- Secondary Outcome Measures
Name Time Method Total cost in admission 3 years Adverse events related to drugs. 3 years Lengths of ICU 3 years The numbers of ARDS patients who meet the criteria for mild, moderate, and severe using the Berlin Definition, separately. 3 years The severity of ARDS will be assessed by the Berlin Definition in mild, moderate and severe ARDs according to oxygenation.
The number of patients who need mechanical ventilation 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
Trial Locations
- Locations (10)
Beijing Shijitan Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Central Hospital of Zi Bo
🇨🇳Zibo, Shandong, China
CANGZHOU People's Hospital
🇨🇳Cangzhou, Hebei, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Anzhen Hospital ,Capital Medical University
🇨🇳Beijing, Beijing, China
The first affiliated hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Chinese Pla General Hospital
🇨🇳Beijing, Beijing, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
The second hospital of dalian medical university
🇨🇳Dalian, Liaoning, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China