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

NCT ID: NCT00839085

Last Updated: 2009-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-03-31

Brief Summary

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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

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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)

Conditions

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CABG-Induced Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

normal procedure of CABG

Group Type NO_INTERVENTION

No interventions assigned to this group

2: GSE

100 mg GSE every 6h /Po, starting one day before surgery (4 doses in 24h)

Group Type ACTIVE_COMPARATOR

GSE

Intervention Type DRUG

grape seed extract (100 mg/6h), PO

3: Vit C

25 mg/kg through pump

Group Type ACTIVE_COMPARATOR

Vit C (Ascorbic Acid)

Intervention Type DRUG

Vit C 25 mg/ kg

Interventions

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GSE

grape seed extract (100 mg/6h), PO

Intervention Type DRUG

Vit C (Ascorbic Acid)

Vit C 25 mg/ kg

Intervention Type DRUG

Other Intervention Names

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Grape Seed Extract Ascorbic Acid

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tabriz University

OTHER

Sponsor Role lead

Responsible Party

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Cardiovascular Research Center

Principal Investigators

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Hossein Babaei, Pharm D, PhD

Role: PRINCIPAL_INVESTIGATOR

Drug Applied Research Center, Tabriz Univ Med Sci

Naser Safaei, MD, Surgeon

Role: STUDY_CHAIR

Tabriz Univ Med Sci

Masood Pezaeshkian, MD

Role: PRINCIPAL_INVESTIGATOR

Tabriz Univ Med Sci

Alireza Yaghobi, MD

Role: PRINCIPAL_INVESTIGATOR

Tabriz Univ Med Sci

Ahmad Reza Jodati, MD

Role: PRINCIPAL_INVESTIGATOR

Tabriz Univ Med Sci

Hossein Babaei, Pharm D, PhD

Role: STUDY_DIRECTOR

Tabriz Univ Med Sci

Rasoul Azarfarin, MD

Role: PRINCIPAL_INVESTIGATOR

Tabriz Univ Med Sci

Mohammad Ali Sheikhalizadeh, CCP

Role: STUDY_DIRECTOR

Tabriz Univ Med Sci

Locations

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Cardiovascular Research Center

Tabriz, East Azerbaijan Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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8710

Identifier Type: -

Identifier Source: org_study_id

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