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Trial registered on ANZCTR


Registration number
ACTRN12612001114831
Ethics application status
Not yet submitted
Date submitted
17/10/2012
Date registered
18/10/2012
Date last updated
5/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The expression of Transient receptor potential melastatintype 2(TRPM2) in the immunocytes of sepsis patients and the role of TRPM2 in the development of sepsis
Scientific title
Increased expression of Transient receptor potential melastatintype (TRPM2) in monocyte and lymphocyte promote the inflammtory cytokines production and lymphocytic apoptosis in sepsis patients
Secondary ID [1] 281404 0
Nil
Universal Trial Number (UTN)
U1111-1135-9112
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 287649 0
Condition category
Condition code
Inflammatory and Immune System 287981 287981 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
10 ml blood drawn from each patient. The plasma, monocyte and lymphocyte will be separated from this 10 ml blood. We only draw 10 ml blood within 24 hours after diagnosis of sepsis
Intervention code [1] 285892 0
Not applicable
Comparator / control treatment
The patients who do not have the inflammation disease are enrolled in control group. 10 ml blood will be drawn from each patient
Control group
Active

Outcomes
Primary outcome [1] 288191 0
To detect the expression of TRPM2 Messenger ribonucleic acid (mRNA) in the monocyte by using real-time Polymerase Chain Reaction (PCR).
Timepoint [1] 288191 0
Within 24 hours after the diagnosis of sepsis in Intensive Care Unit (ICU). We only draw blood from the sepsis patients once.
Primary outcome [2] 288192 0
To detect the expression of TRPM2 mRNA in the lymphocyte by using real-time PCR.
Timepoint [2] 288192 0
Within 24 hours after the diagnosis of sepsis in Intensive Care Unit (ICU). We only draw blood from the sepsis patients once.
Secondary outcome [1] 299585 0
infammatory cytokines (TNFa, IL-6, IL-8, IL-10) in the plasma of sepsis patients
Timepoint [1] 299585 0
Within 24 hours after the diagnosis of sepsis in ICU. We only draw blood from the sepsis patients once.
Secondary outcome [2] 299586 0
To detect immunocyte apoptosis in sepsis patients by using flow cytometer.
Timepoint [2] 299586 0
Within 24 hours after the diagnosis of sepsis in ICU. We only draw blood from the sepsis patients once.
Secondary outcome [3] 299587 0
To assess the physiology and health of patients by using acute physiology and chronic health evaluation (APACHE )score.

Using sepsis-related Organ Failure (SOFA) score, the organ damage of sepsis patients will be assessed.
Timepoint [3] 299587 0
Within 24 hours after the diagnosis of sepsis in ICU. We assess the scores only once.

Eligibility
Key inclusion criteria
sepsis patients including sepsis, severe sepsis and sepsis shock patients.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not sepsis patients

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 4604 0
China
State/province [1] 4604 0
Zhejiang

Funding & Sponsors
Funding source category [1] 286162 0
Government body
Name [1] 286162 0
The national outstanding youth fund
Country [1] 286162 0
China
Primary sponsor type
Individual
Name
Xiangming Fang
Address
Department of Anaesthesiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Qingchun Road 79, Hangzhou 310003, China.
Country
China
Secondary sponsor category [1] 284977 0
Individual
Name [1] 284977 0
Xiaowei Qian
Address [1] 284977 0
Department of Anaesthesiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Qingchun Road 79, Hangzhou 310003, China.
Country [1] 284977 0
China

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288225 0
Ethics committee of the First Affiliated Hospital, College of Medicine, Zhejiang University
Ethics committee address [1] 288225 0
Ethics committee country [1] 288225 0
China
Date submitted for ethics approval [1] 288225 0
18/11/2012
Approval date [1] 288225 0
15/03/2013
Ethics approval number [1] 288225 0
supplement 207

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34841 0
Dr Xiaowei Qian
Address 34841 0
Department of Anesthesiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Qingchun Road 79, Hangzhou 310003, China.
Country 34841 0
China
Phone 34841 0
+8613645714949
Fax 34841 0
Email 34841 0
qxwzhejiangedu@163.com
Contact person for public queries
Name 18088 0
Xiaowei Qian
Address 18088 0
Department of Anaesthesiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Qingchun Road 79, Hangzhou 310003, China.
Country 18088 0
China
Phone 18088 0
+86 13645714949
Fax 18088 0
Email 18088 0
qxwzhejangedu@163.com
Contact person for scientific queries
Name 9016 0
Xiaowei Qian
Address 9016 0
Department of Anaesthesiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Qingchun Road 79, Hangzhou 310003, China.
Country 9016 0
China
Phone 9016 0
+86 13645714949
Fax 9016 0
Email 9016 0
qxwzhejangedu@163.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.