Ulinastatin in Inhalation Lung Injury

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01287806

Enrollment

120

Registered

2011-02-01

Start date

2011-02-28

Completion date

2013-01-31

Last updated

2011-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inhalation Injury

Keywords

ulinastatin, inhalation injury

Brief summary

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

Interventions

DRUGulinastatin

Resolved 4 vials of drugs in 100ml physiological saline solution,intravenously infused for 1-2h,tid,for continuous 10days

DRUGblank group

standard treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

China

Contacts

Primary ContactSheng zhiyong, MD

86-13910008199

Backup ContactJia chiyu, MD

JCY304@yahoo.com.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026