Ulinastatin in Inhalation Lung Injury

Inhalation Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01287806
• Other study ID #: Uilis-china
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 24, 2011
• Last updated: January 31, 2011
• Start date: February 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2011
• Source: Chinese PLA General Hospital
• Contact: Sheng zhiyong, MD
• Phone: 86-13910008199
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inhalation Injury
• Lung Injury
• Respiratory Aspiration

Intervention

Drug:
• ulinastatin
Resolved 4 vials of drugs in 100ml physiological saline solution,intravenously infused for 1-2h,tid,for continuous 10days
• blank group
standard treatment

Locations

Country	Name	City	State
China	304 hospital of PLA	Beijin	Beijin

Sponsors (4)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Changhai Hospital, General Hospital of Beijing PLA Military Region, Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

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