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Ulinastatin in Inhalation Lung Injury

Primary Purpose

Inhalation Injury

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

ulinastatin

blank group

About this trial

This is an interventional treatment trial for Inhalation Injury focused on measuring ulinastatin, inhalation injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

304 hospital of PLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

blank control group

ulinastatin group

Arm Description

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

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

length of mechanical ventilation

length of ICU stay

length of hospital stays

blood inflammatory mediator

Bronchoscopy morphological evaluation

Full Information

NCT ID

NCT01287806

First Posted

January 24, 2011

Last Updated

January 31, 2011

Sponsor

Chinese PLA General Hospital

Collaborators

Changhai Hospital, Southwest Hospital, China, General Hospital of Beijing PLA Military Region

1. Study Identification

Unique Protocol Identification Number

NCT01287806

Brief Title

Ulinastatin in Inhalation Lung Injury

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

February 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese PLA General Hospital

Collaborators

Changhai Hospital, Southwest Hospital, China, General Hospital of Beijing PLA Military Region

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inhalation Injury

Keywords

ulinastatin, inhalation injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

blank control group

Arm Type

Sham Comparator

Arm Title

ulinastatin group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ulinastatin

Other Intervention Name(s)

brand name: noan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

blank group

Intervention Description

standard treatment

Primary Outcome Measure Information:

Title

all cause mortality

Time Frame

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

Secondary Outcome Measure Information:

Title

length of mechanical ventilation

Time Frame

from admission to 90 days

Title

length of ICU stay

Time Frame

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

Title

length of hospital stays

Time Frame

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

Title

blood inflammatory mediator

Time Frame

0days,5days and 10days

Title

Bronchoscopy morphological evaluation

Time Frame

0days,5days and 10days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sheng zhiyong, MD

Phone

86-13910008199

First Name & Middle Initial & Last Name or Official Title & Degree

Jia chiyu, MD

JCY304@yahoo.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

sheng zhiyong, MD

Organizational Affiliation

First Hospitals affiliated to the China PLA General Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jia chiyu, MD

Organizational Affiliation

First Hospitals affiliated to the China PLA General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xia zhaofan, MD

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pang yizhi, MD

Organizational Affiliation

Southwest Hospital, China

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chen tunhu, MD

Organizational Affiliation

General Hospital of Jinan PLA Military Region

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zhu jinmin, MD

Organizational Affiliation

General Hospital of Beijing PLA Military Region

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Liu yi, MD

Organizational Affiliation

General Hospital of Lanzhou PLA Military Region

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Cui xiaolin, MD

Organizational Affiliation

Liaonin People's Armed Police Corps Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sheng guanyu, MD

Organizational Affiliation

187 Central Hospital of the Chinese PLA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lu qinjun, MD

Organizational Affiliation

251 Central Hospital of the Chinese PLA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shi shengfu, MD

Organizational Affiliation

322 Central Hospital of the Chinese PLA

Official's Role

Principal Investigator

Facility Information:

Facility Name

304 hospital of PLA

City

Beijin

State/Province

Beijin

ZIP/Postal Code

100000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sheng zhiyong, MD

Phone

86-13910008199

First Name & Middle Initial & Last Name & Degree

Jia chiyu, MD

JCY304@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Jia chiyu, MD

12. IPD Sharing Statement

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Ulinastatin in Inhalation Lung Injury

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