Ulinastatin in Inhalation Lung Injury

NCT01287806 | Unknown Phase 2

• 1 other identifier: Uilis-china
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inhalation Injury

Keywords

ulinastatin; inhalation injury

Outcome Measures

Primary Outcomes (1)

• all cause mortality

  until death or discharge from hospital, data reviewed every 3 months

Secondary Outcomes (5)

• 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

Study Arms (2)

blank control group

SHAM COMPARATOR

Drug: blank group

ulinastatin group

EXPERIMENTAL

ulinastatin is a multivalent kunitz-type serine protease inhibitor refined from human urine

Drug: ulinastatin

Interventions

ulinastatin DRUG

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

Also known as: brand name: noan

ulinastatin group

blank group DRUG

standard treatment

blank control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or lactation
• Allergy for ulinastatin
• Received an investigational drug or device within 90 days prior to entering study

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Changhai Hospital: collaborator
• Southwest Hospital, China: collaborator
• General Hospital of Beijing PLA Military Region: collaborator

Study Sites (1)

304 hospital of PLA

Beijin, Beijin, 100000, China

Location

MeSH Terms

Interventions

urinastatin

Study Officials

• sheng zhiyong, MD

  First Hospitals affiliated to the China PLA General Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng zhiyong, MD

CONTACT

86-13910008199

Jia chiyu, MD

CONTACT

JCY304@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: February 1, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: February 1, 2011

Record last verified: 2011-01

Locations

CN (1)