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

Tracking Information

First Received Date ^ICMJE

February 6, 2009

Last Updated Date

February 9, 2009

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

LVEF [ Time Frame: Before and after CABG ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00839085 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effect of Ascorbic Acid and Grape Seed Extract "Vitis Vinifera L." in Oxidative Stress Induced by on Pump Coronary Artery by Pass Grafting Surgery

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.

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).

Control
GSE (100 mg/6h - PO, 24h before surgery)
Vit C (25 mg/kg in pump circulation during surgery)

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care

Condition ^ICMJE

CABG-Induced Oxidative Stress

Intervention ^ICMJE

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

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

March 2009

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT00839085

Other Study ID Numbers ^ICMJE

8710

Has Data Monitoring Committee

Responsible Party

Dr Naser Safaei, Cardiovascular Research Center

Study Sponsor ^ICMJE

Tabriz University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Tabriz University

Verification Date

February 2009

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

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