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

February 9, 2009 updated by: Tabriz University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • East Azerbaijan
      • Tabriz, East Azerbaijan, Iran, Islamic Republic of, 51656-65811
        • Cardiovascular Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • Grape Seed Extract
ACTIVE_COMPARATOR: 3: Vit C
25 mg/kg through pump
Drug: Vit C (Ascorbic Acid)
Vit C 25 mg/ kg
Other Names:
  • Ascorbic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LVEF
Time Frame: Before and after CABG
Before and after CABG

Secondary Outcome Measures

Outcome Measure
Time Frame
Total Antioxidant Capacity (TAC)
Time Frame: Before ischemia, after ischemia, after reperfusion
Before ischemia, after ischemia, after reperfusion
MDA
Time Frame: Before, middle and after CABG
Before, middle and after CABG
GTX
Time Frame: Before ischemia, after ischemia, after reperfusion
Before ischemia, after ischemia, after reperfusion
SOD
Time Frame: Before ischemia, after ischemia, after reperfusion
Before ischemia, after ischemia, after reperfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ANTICIPATED)

January 1, 2009

Study Completion (ANTICIPATED)

March 1, 2009

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (ESTIMATE)

February 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8710

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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