Ulinastatin in Inhalation Lung Injury

January 31, 2011 updated by: Chinese PLA General Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijin
      • Beijin, Beijin, China, 100000
        • 304 Hospital of PLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimate)

February 1, 2011

Study Record Updates

Last Update Posted (Estimate)

February 1, 2011

Last Update Submitted That Met QC Criteria

January 31, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uilis-china

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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