Ulinastatin in Inhalation Lung Injury
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Chinese PLA General Hospital.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Chinese PLA General Hospital
Collaborators:
Changhai Hospital
Southwest Hospital, China
General Hospital of Beijing PLA Military Region
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01287806
First received: January 24, 2011
Last updated: January 31, 2011
Last verified: January 2011
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Purpose
The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Inhalation Injury |
Drug: ulinastatin Drug: blank group |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter,Randomized,Parallel Assignment,Blank Control Study of Ulinastatin in Inhalation Lung Injury |
Further study details as provided by Chinese PLA General Hospital:
Primary Outcome Measures:
- all cause mortality [ Time Frame: until death or discharge from hospital, data reviewed every 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- length of mechanical ventilation [ Time Frame: from admission to 90 days ] [ Designated as safety issue: No ]
- length of ICU stay [ Time Frame: until death or discharge from hospital, data reviewed every 3 months ] [ Designated as safety issue: No ]
- length of hospital stays [ Time Frame: until death or discharge from hospital, data reviewed every 3 months ] [ Designated as safety issue: No ]
- blood inflammatory mediator [ Time Frame: 0days,5days and 10days ] [ Designated as safety issue: No ]
- Bronchoscopy morphological evaluation [ Time Frame: 0days,5days and 10days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Sham Comparator: blank control group |
Drug: blank group
standard treatment
|
|
Experimental: ulinastatin group
ulinastatin is a multivalent kunitz-type serine protease inhibitor refined from human urine
|
Drug: ulinastatin
Resolved 4 vials of drugs in 100ml physiological saline solution,intravenously infused for 1-2h,tid,for continuous 10days
Other Name: brand name: noan
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287806
Contacts
| Contact: Sheng zhiyong, MD | 86-13910008199 | |
| Contact: Jia chiyu, MD | JCY304@yahoo.com.cn |
Locations
| China, Beijin | |
| 304 hospital of PLA | Not yet recruiting |
| Beijin, Beijin, China, 100000 | |
| Contact: Sheng zhiyong, MD 86-13910008199 | |
| Contact: Jia chiyu, MD JCY304@yahoo.com.cn | |
| Principal Investigator: Jia chiyu, MD | |
Sponsors and Collaborators
Chinese PLA General Hospital
Changhai Hospital
Southwest Hospital, China
General Hospital of Beijing PLA Military Region
Investigators
| Study Chair: | sheng zhiyong, MD | First Hospitals affiliated to the China PLA General Hospital |
| Principal Investigator: | Jia chiyu, MD | First Hospitals affiliated to the China PLA General Hospital |
| Principal Investigator: | Xia zhaofan, MD | Changhai Hospital |
| Principal Investigator: | Pang yizhi, MD | Southwest Hospital, China |
| Principal Investigator: | Chen tunhu, MD | General Hospital of Jinan PLA Military Region |
| Principal Investigator: | Zhu jinmin, MD | General Hospital of Beijing PLA Military Region |
| Principal Investigator: | Liu yi, MD | General Hospital of Lanzhou PLA Military Region |
| Principal Investigator: | Cui xiaolin, MD | Liaonin People's Armed Police Corps Hospital |
| Principal Investigator: | Sheng guanyu, MD | 187 Central Hospital of the Chinese PLA |
| Principal Investigator: | Lu qinjun, MD | 251 Central Hospital of the Chinese PLA |
| Principal Investigator: | Shi shengfu, MD | 322 Central Hospital of the Chinese PLA |
More Information
No publications provided
| Responsible Party: | Sheng Zhiyong, General Hospital of the People's Liberation Army |
| ClinicalTrials.gov Identifier: | NCT01287806 History of Changes |
| Other Study ID Numbers: | Uilis-china |
| Study First Received: | January 24, 2011 |
| Last Updated: | January 31, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Chinese PLA General Hospital:
|
ulinastatin inhalation injury |
Additional relevant MeSH terms:
|
Respiratory Aspiration Lung Injury Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Lung Diseases Thoracic Injuries |
Wounds and Injuries Urinastatin Trypsin Inhibitors Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013