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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Thoracic Injuries
Respiratory Aspiration
Lung Injury
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Lung Diseases
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 October 19, 2014