Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000075785
Ethics application status
Approved
Date submitted
17/01/2013
Date registered
21/01/2013
Date last updated
24/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pro-inflammatory mediators and oxidative stress in liver transplantation patients
Scientific title
Pro-inflammatory mediators and oxidative stress in liver transplantation patients
Secondary ID [1] 281795 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
end stage of liver failure 288119 0
Condition category
Condition code
Surgery 288496 288496 0 0
Other surgery
Oral and Gastrointestinal 288510 288510 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We have attempted to analyze the blood samples for measurement of pro-inflammatory mediators and oxidative stress before liver tranaplantation in the operation room. The approximate duration that measurements take in each patient is 5 minutes only. In addition, single blood sample is taken from vein.
Intervention code [1] 286339 0
Not applicable
Comparator / control treatment
Assessment of pro-inflammatory mediators and oxidative stress in a sub-group of healthy controls
Control group
Active

Outcomes
Primary outcome [1] 288654 0
The primary objective of this study is to determine the pro-inflammatory mediators and oxidative stress in liver tranaplantation recepients compared to healthy controls. Participants will provide a single fasting blood sample from which plasma pro-inflammatory mediators and oxidative stress levels will be determined. Results will be compared between the study populations using an analysis of variance (ANOVA) to determine if a difference exists.
Timepoint [1] 288654 0
Single-point assessment
Secondary outcome [1] 300702 0
The secondary objective of this study is to determine the rate and extent of superoxide production and elastase activity from neutrophils in liver tranaplantation recepients compared to healthy controls. The assay of the generation of superoxide is based on the superoxide dismutase (SOD)-inhibitable reduction of ferricytochrome c. Changes in absorbance with the reduction of ferricytochrome c at 550 nm are continuously monitored with a double-beam, six-cell positioner spectrophotometer with constant stirring (Hitachi U-3010, Tokyo, Japan). Degranulation of azurophilic granules is determined by elastase activity. Changes in absorbance at 405 nm are continually monitored for 15 min to determine elastase activity with a double-beam, six-cell positioner spectrophotometer with constant stirring (Hitachi U-3010, Tokyo, Japan). Results will be compared between the study populations using an analysis of variance (ANOVA) to determine if a difference exists.
Timepoint [1] 300702 0
Single-point assessment

Eligibility
Key inclusion criteria
1. Participant is >=18 years of age at the time of informed consent.
2. Participant is a male or non-pregnant, non-lactating female.
3. Participant is either:
i. a patient diagnosed with end stage liver failure by a physician according to the standard diagnostic criteria; or
ii. a healthy subject with no clinically significant conditions.
4. Participant is aware of the study procedures and the risks involved and voluntarily agrees to participate by providing written informed consent.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with sepsis, shock, hepatoencephalopathy, hepatorenal syndrome, severe pulmonary hypertension (>35mmHg), or antioxidants taking recently, as well as patients with massive ascites or pleural effusion were excluded.
2. Participant has a history or current evidence of any condition, therapy or laboratory abnormality that, in the opinion of the investigator, might affect the results of the study or may not be in the best interest of the individual to participate.
3. Participant has participated in a clinical trial within 2 months of study participation that, in the opinion of the investigator, might affect the results of the study or may not be in the best interest of the individual to participate.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4803 0
Taiwan, Province Of China
State/province [1] 4803 0

Funding & Sponsors
Funding source category [1] 286580 0
Self funded/Unfunded
Name [1] 286580 0
Huang-Ping Yu
Country [1] 286580 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Yung-Fong Tsai
Address
Chang Gung Memorial Hospital
5 Fu-shin street, Kwei-shan, Taoyuan, Taiwan 333
Country
Taiwan, Province Of China
Secondary sponsor category [1] 285364 0
Individual
Name [1] 285364 0
Huang-Ping Yu
Address [1] 285364 0
Chang Gung Memorial Hospital
5 Fu-shin street, Kwei-shan, Taoyuan, Taiwan 333
Country [1] 285364 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288657 0
Chang Gung Medical Foundation
Ethics committee address [1] 288657 0
Ethics committee country [1] 288657 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 288657 0
07/10/2009
Approval date [1] 288657 0
07/12/2009
Ethics approval number [1] 288657 0
98-3402C

Summary
Brief summary
Single fasting blood samples will be collected from each study participant for analysis of pro-inflammatory mediators and oxidative stress. At the time of blood sample collection, isolated neutrophils will be for measurement of superoxide production and elastase activity.
Results of pro-inflammatory mediators and oxidative stress obtained from liver tranaplantation recepients will be statistically compared to those obtained from healthy controls using analysis of variance (ANOVA).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37138 0
Dr Yung-Fong Tsai
Address 37138 0
Chang Gung Memorial Hospital
5 Fu-shin street, Kwei-shan, Taoyuan, Taiwan 333
Country 37138 0
Taiwan, Province Of China
Phone 37138 0
886-3-3281200ext2324
Fax 37138 0
Email 37138 0
l12084@adm.cgmh.org.tw
Contact person for public queries
Name 37139 0
Yung-Fong Tsai
Address 37139 0
5 Fu-shin street, Kwei-shan, Taoyuan, Taiwan 333
Country 37139 0
Taiwan, Province Of China
Phone 37139 0
886-3-3281200ext2324
Fax 37139 0
Email 37139 0
l12084@adm.cgmh.org.tw
Contact person for scientific queries
Name 37140 0
Yung-Fong Tsai
Address 37140 0
5 Fu-shin street, Kwei-shan, Taoyuan, Taiwan 333
Country 37140 0
Taiwan, Province Of China
Phone 37140 0
886-3-3281200ext2324
Fax 37140 0
Email 37140 0
l12084@adm.cgmh.org.tw

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
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Documents added automatically
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