The aim of this research is studying the effect of Ascorbic Acid administration on the expression of related inflammatory cytokine genes, so that we can present a solution to reduce organ injury and improve graft consequences after intensification of inflammatory responses in brain-dead liver donors.
10 up to 60 year-old brain-dead liver donors who are admitted in Namazi hospital and receive intensive care in ICU will be randomly classified into 2 groups: intervention and control. The intervention group cases receive only Ascorbic Acid with primary doze of 100 mg/kg, 6 hours before operation and immediately it will be continued with Ascorbic Acid infusion with doze of 100 mg/kg (per 6h) until the end of surgery and organ removal. The members of control group receive only routine care of ICU.
The blood sample will be taken from every case at 3 times:
- 6 hours before starting of donor operation (in intervention group before Ascorbic Acid administration)
- Immediately after laparotomy
- Immediately before Aorta clamping.
At the end, expression level of related genes and function of transplanted liver will be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012081710619N1
Registration date:2013-02-25, 1391/12/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-25, 1391/12/07
Registrant information
Name
Masoumeh Kazemi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1234 9610
Email address
kazemima@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice- Chancellor of Shiraz University of Medical Science
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Ascorbic Acid administration effect on gene expression level of IL6 and TNF-α cytokines among brain-dead liver donors
Public title
The effect of Ascorbic Acid administration on inflammatory responses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 10-60 y/o confirmed deadbrain case who has the UNOS standard criteria
Exclusion criteria: The deadbrain patient who had a cardiac arrest
Age
From 10 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand St, Shiraz University of Medical Sciences
City
Shiraz
Postal code
71348-14336
Approval date
2012-07-26, 1391/05/05
Ethics committee reference number
CT-91-6173
Health conditions studied
1
Description of health condition studied
Exacerbation of inflammatory responses following brain-death occurrence
ICD-10 code
R00-R99
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
Primary outcomes
1
Description
Gene expression levels of IL6 and TNF-a genes
Timepoint
- 6 hours before the operation of deadbrain donor (in intervention group before starting to intervention) -Immediately after laparotomy -Immediately before clamping of Aorta
Method of measurement
Gene expression analysis using Real-Time PCR method
Secondary outcomes
1
Description
Serum levels of AST, ALT and Bilirubin -T
Timepoint
1, 3 and 10 days afetr liver transplantation
Method of measurement
Serum levels of AST, ALT and Bilirubin-T
Intervention groups
1
Description
Intervention Group: 100 mg/kg Ascorbic Acid administration and then starting to Continuous infusion of vit C, 100 mg/kg/p6h until the end of donor operation
Control Group: without intervention
Category
Treatment - Drugs
2
Description
Control group: routine practice
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Dr Mohammad Bagher Khosarvi
Street address
Namazi hospital, Zand St
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
Zand st, Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Kazemi
Position
MSc Student of Human Genetics
Other areas of specialty/work
Street address
Medical Genetics Department, Medical Faculty, Setad Square
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1234 9610
Fax
+98 71 1234 9610
Email
Kazemima@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Scienses
Full name of responsible person
Dr Mohammad Bagher Tabei
Position
Associated professor
Other areas of specialty/work
Street address
Medical Genetics Department, Medical Faculty, Setad Square
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1234 9610
Fax
+98 71 1234 9610
Email
tabeismb@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Kazemi
Position
MSc student of Human Genetics
Other areas of specialty/work
Street address
Medical Genetics Department, Medical Faculty, Setad Square
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1234 9610
Fax
+98 71 1234 9610
Email
kazemima@sums.ac
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)