Inhalation Injury Clinical Trial
Official title:
Multicenter,Randomized,Parallel Assignment,Blank Control Study of Ulinastatin in Inhalation Lung Injury
The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | January 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Moderate to severe inhalation lung injury - Within 48hours after inhalation injury - Age 18 to 70 years old - Burned area not more than 70% TBSA - Signed the informed consent form Exclusion Criteria: - Pregnancy or lactation - Allergy for ulinastatin - Received an investigational drug or device within 90 days prior to entering study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | 304 hospital of PLA | Beijin | Beijin |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital | Changhai Hospital, General Hospital of Beijing PLA Military Region, Southwest Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | all cause mortality | until death or discharge from hospital, data reviewed every 3 months | No | |
Secondary | length of mechanical ventilation | from admission to 90 days | No | |
Secondary | length of ICU stay | until death or discharge from hospital, data reviewed every 3 months | No | |
Secondary | length of hospital stays | until death or discharge from hospital, data reviewed every 3 months | No | |
Secondary | blood inflammatory mediator | 0days,5days and 10days | No | |
Secondary | Bronchoscopy morphological evaluation | 0days,5days and 10days | No |
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