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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
History of Changes
  Purpose

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 Intervention
CABG-Induced Oxidative Stress
 Drug: GSE
Drug: Vit C (Ascorbic Acid)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tabriz University:

Primary Outcome Measures:
  • LVEF [ Time Frame: Before and after CABG ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: November 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839085

Locations
Iran, Islamic Republic of
Cardiovascular Research Center
Tabriz, East Azerbaijan, Iran, Islamic Republic of, 51656-65811
Sponsors and Collaborators
Tabriz University
Investigators
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

No publications provided

Responsible Party: Dr Naser Safaei, Cardiovascular Research Center
ClinicalTrials.gov Identifier: NCT00839085     History of Changes
Other Study ID Numbers: 8710
Study First Received: February 6, 2009
Last Updated: February 9, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Tabriz University:
CABG
on pump
Grape seed extract
Vit C
Oxidative stress

Additional relevant MeSH terms:
Ascorbic Acid
Grape Seed Extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
 Vitamins
Micronutrients
Growth Substances
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013