Ulinastatin in Inhalation Lung Injury

Phase 2

• Conditions: Inhalation Injury
• Interventions: Drug: blank group; Drug: ulinastatin

• Registration Number: NCT01287806
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-31
• Last Update Submitted: 2011-01-31
• Study Start: 2011-02
• Study First Posted: 2011-02-01
• Last Update Posted: 2011-02-01
• Primary Completion: 2012-12
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
blank control group	blank group	-
ulinastatin group	ulinastatin	ulinastatin is a multivalent kunitz-type serine protease inhibitor refined from human urine

Primary Outcome Measures

Name	Time	Method
all cause mortality	until death or discharge from hospital, data reviewed every 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

304 hospital of PLA; 🇨🇳 Beijin, Beijin, China