This study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery bypass grafting surgery. There are three groups in the study. 75 candidates of coronary artery bypass grafting surgery were randomly assigned to each study group (25 in each group). 1. Control 2. Grape Seed Extract (100 mg/6h - PO, 24h before surgery) 3. Vit C (25 mg/kg in pump circulation during surgery). Inclusion Criteria: Candidates for elective CABG surgery with pump for first time, 3 Vessel Disease (3VD). Exclusion Criteria: High risk patients, Those who need another heart surgery beside CABG, Urgent patients, Diabetics, Ischemic time more than 120 min. We will compare Left Ventricular Ejection Fraction and Total Antioxidant Capacity between groups before and after the interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138708271460N1
Registration date:2009-02-16, 1387/11/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-02-16, 1387/11/28
Registrant information
Name
Hossein Babaei
Name of organization / entity
Drug Applies Research Center, Tabriz Univ Med Sci
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3311
Email address
babaeih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2008-11-01, 1387/08/11
Expected recruitment end date
2009-03-31, 1388/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ascorbic Acid and Grape Seed Extract "Vitis Vinifera L." on Oxidative Stress Induced by on Pump Coronary Artery by Pass Grafting Surgery
Public title
Comparison of Ascorbic Acid and Grape Seed Extract in Oxidative Stress Induced by on Pump Heart Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Candidates for elective CABG surgery with pump for first time, 3 Vessel Disease (3VD).
Exclusion Criteria: High risk patients, Those who need another heart surgery beside CABG, Urgent patients Diabetics, Ischemic time more than 120 min.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT00839085
Registration date
2009-02-06, 1387/11/18
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Ethical Committee of Tabriz University of Medical Sciences
Street address
Daneshgah St,Tabriz University of Medical Sciences
City
Tabriz
Postal code
51656-65811
Approval date
2009-01-05, 1387/10/16
Ethics committee reference number
8710
Health conditions studied
1
Description of health condition studied
Coronary Atrery Bypass Graft (CABG)
ICD-10 code
I20, I21,
ICD-10 code description
Ischaemic heart diseases
2
Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
3
Description of health condition studied
Ischaemic cardiomyopathy
ICD-10 code
I25.5
ICD-10 code description
Ischaemic cardiomyopathy
Primary outcomes
1
Description
Left Ventricular Ejection Fraction (LVEF)
Timepoint
Before and after CABG
Method of measurement
Trans Thoracic Echocardiography (TTE)
Secondary outcomes
1
Description
Total Antioxidant Capacity (TAC)
Timepoint
Before, middle and after CABG
Method of measurement
Biochemistry (blood sample)
Intervention groups
1
Description
Control Group: without intervention
Category
N/A
2
Description
Grape Seed Extract 100 mg/6h
Category
Treatment - Drugs
3
Description
Vit C 25 mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Cardiovascular Research Center
Full name of responsible person
Dr Naser Safaei
Street address
Daneshgah St,Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz Univ Med Sci
Full name of responsible person
Vice Chancellor for research (Dr Kazemi)
Street address
Daneshgah St,Tabriz Univ Med Sci
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz Univ Med Sci
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
Tabriz Univ Med Sci
Full name of responsible person
Naser safaei, MD, Surgeon
Position
Associate Prof., MD, Cardiac Surgeon
Other areas of specialty/work
Street address
Tabriz Univ Med Sci
City
Tabriz
Postal code
51656-65811
Phone
+98 41 1335 7767
Fax
Email
drsafaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Univ Med Sci
Full name of responsible person
Dr Naser Safaei
Position
MD, Cardiac surgoen, Associate Prof
Other areas of specialty/work
Street address
Daneshgah St,Tabriz Univ Med Sci
City
Tabriz
Postal code
51656-65811
Phone
+98 41 1335 7767
Fax
Email
drsafaei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Drug Applied Research Center
Full name of responsible person
Dr Hossein Babaei
Position
Professor of Cardiovascular Pharmacology
Other areas of specialty/work
Street address
Drug Applied Research Center, Tabriz Univ Med Sci
City
Tabriz
Postal code
51656-65811
Phone
+98 41 1336 3311
Fax
Email
babaeih@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)