Comparison of Ascorbic Acid and Grape Seed Extract in Oxidative Stress Induced by on Pump Heart Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Tabriz University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT00839085
First received: February 6, 2009
Last updated: February 9, 2009
Last verified: February 2009

February 6, 2009
February 9, 2009
November 2008
January 2009   (final data collection date for primary outcome measure)
LVEF [ Time Frame: Before and after CABG ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00839085 on ClinicalTrials.gov Archive Site
  • Total Antioxidant Capacity (TAC) [ Time Frame: Before ischemia, after ischemia, after reperfusion ] [ Designated as safety issue: No ]
  • MDA [ Time Frame: Before, middle and after CABG ] [ Designated as safety issue: No ]
  • GTX [ Time Frame: Before ischemia, after ischemia, after reperfusion ] [ Designated as safety issue: No ]
  • SOD [ Time Frame: Before ischemia, after ischemia, after reperfusion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Ascorbic Acid and Grape Seed Extract in Oxidative Stress Induced by on Pump Heart Surgery
Effect of Ascorbic Acid and Grape Seed Extract "Vitis Vinifera L." in Oxidative Stress Induced by on Pump Coronary Artery by Pass Grafting Surgery

Study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.

This study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.

There are three groups in the study. 75 candidate of coronary artery by pass grafting surgery were assigned random allocation on the groups (25 in each group).

  1. Control
  2. GSE (100 mg/6h - PO, 24h before surgery)
  3. Vit C (25 mg/kg in pump circulation during surgery)
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
CABG-Induced Oxidative Stress
  • Drug: GSE
    grape seed extract (100 mg/6h), PO
    Other Name: Grape Seed Extract
  • Drug: Vit C (Ascorbic Acid)
    Vit C 25 mg/ kg
    Other Name: Ascorbic Acid
  • No Intervention: 1
    normal procedure of CABG
  • Active Comparator: 2: GSE
    100 mg GSE every 6h /Po, starting one day before surgery (4 doses in 24h)
    Intervention: Drug: GSE
  • Active Comparator: 3: Vit C
    25 mg/kg through pump
    Intervention: Drug: Vit C (Ascorbic Acid)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
March 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Candidates for elective CABG surgery with pump for first time
  • 3VD

Exclusion Criteria:

  • High risk patients
  • Those who need another heart surgery beside CABG
  • Urgent patients
  • Diabetics
  • Ischemic time more than 120 min
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00839085
8710
No
Dr Naser Safaei, Cardiovascular Research Center
Tabriz University
Not Provided
Principal Investigator: Hossein Babaei, Pharm D, PhD Drug Applied Research Center, Tabriz Univ Med Sci
Study Chair: Naser Safaei, MD, Surgeon Tabriz Univ Med Sci
Principal Investigator: Masood Pezaeshkian, MD Tabriz Univ Med Sci
Principal Investigator: Alireza Yaghobi, MD Tabriz Univ Med Sci
Principal Investigator: Ahmad Reza Jodati, MD Tabriz Univ Med Sci
Study Director: Hossein Babaei, Pharm D, PhD Tabriz Univ Med Sci
Principal Investigator: Rasoul Azarfarin, MD Tabriz Univ Med Sci
Study Director: Mohammad Ali Sheikhalizadeh, CCP Tabriz Univ Med Sci
Tabriz University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP