Ulinastatin in Inhalation Lung Injury

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01287806

Collaborator

Changhai Hospital (Other), Southwest Hospital, China (Other), General Hospital of Beijing PLA Military Region (Other)

120

Enrollment

Location

Arms

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.

Condition or Disease	Intervention/Treatment	Phase
Inhalation Injury	Drug: ulinastatin Drug: blank group	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multicenter,Randomized,Parallel Assignment,Blank Control Study of Ulinastatin in Inhalation Lung Injury

Study Start Date :

Feb 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: brand name: noan

Arm

Intervention/Treatment

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 Names:

brand name: noan

Outcome Measures

Primary Outcome Measures

all cause mortality [until death or discharge from hospital, data reviewed every 3 months]

Secondary Outcome Measures

length of mechanical ventilation [from admission to 90 days]
length of ICU stay [until death or discharge from hospital, data reviewed every 3 months]
length of hospital stays [until death or discharge from hospital, data reviewed every 3 months]
blood inflammatory mediator [0days,5days and 10days]
Bronchoscopy morphological evaluation [0days,5days and 10days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	304 hospital of PLA	Beijin	Beijin	China	100000

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