Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00839085
Recruitment Status : Unknown
Verified February 2009 by Tabriz University.
Recruitment status was:  Active, not recruiting
First Posted : February 9, 2009
Last Update Posted : February 10, 2009
Sponsor:
Information provided by:
Tabriz University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
CABG-Induced Oxidative Stress Drug: GSE Drug: Vit C (Ascorbic Acid) Not Applicable

Detailed Description:

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)
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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 Start Date : November 2008
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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)
 Drug: GSE
grape seed extract (100 mg/6h), PO
Other Name: Grape Seed Extract
Active Comparator: 3: Vit C
25 mg/kg through pump
 Drug: Vit C (Ascorbic Acid)
Vit C 25 mg/ kg
Other Name: Ascorbic Acid


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. LVEF [ Time Frame: Before and after CABG ]

Secondary Outcome Measures :
  1. Total Antioxidant Capacity (TAC) [ Time Frame: Before ischemia, after ischemia, after reperfusion ]
  2. MDA [ Time Frame: Before, middle and after CABG ]
  3. GTX [ Time Frame: Before ischemia, after ischemia, after reperfusion ]
  4. SOD [ Time Frame: Before ischemia, after ischemia, after reperfusion ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839085


Locations
Layout table for location information
Iran, Islamic Republic of
Cardiovascular Research Center
Tabriz, East Azerbaijan, Iran, Islamic Republic of, 51656-65811
Sponsors and Collaborators
Tabriz University
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr Naser Safaei, Cardiovascular Research Center
ClinicalTrials.gov Identifier: NCT00839085    
Other Study ID Numbers: 8710
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009
Keywords provided by Tabriz University:
CABG
on pump
Grape seed extract
Vit C
Oxidative stress
Additional relevant MeSH terms:
Layout table for MeSH terms
Ascorbic Acid
Grape Seed Extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
 Physiological Effects of Drugs
Vitamins
Micronutrients
Antineoplastic Agents, Phytogenic
Antineoplastic Agents