Pro-inflammatory mediators and oxidative stress in liver transplantation patients

Not Applicable

Completed

• Conditions: end stage of liver failure; Surgery - Other surgery; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12613000075785
• Lead Sponsor: Yung-Fong Tsai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Single-point assessment]

Secondary Outcome Measures

Name	Time	Method
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.[Single-point assessment]