Overview

This trial is active, not recruiting.

Condition cabg-induced oxidative stress
Treatments gse, vit c (ascorbic acid)
Sponsor Tabriz University
Start date November 2008
End date January 2009
Trial size 72 participants
Trial identifier NCT00839085, 8710

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose supportive care
Arm
(No Intervention)
normal procedure of CABG
(Active Comparator)
100 mg GSE every 6h /Po, starting one day before surgery (4 doses in 24h)
gse Grape Seed Extract
grape seed extract (100 mg/6h), PO
(Active Comparator)
25 mg/kg through pump
vit c (ascorbic acid) Ascorbic Acid
Vit C 25 mg/ kg

Primary Outcomes

Measure
LVEF
time frame: Before and after CABG

Secondary Outcomes

Measure
Total Antioxidant Capacity (TAC)
time frame: Before ischemia, after ischemia, after reperfusion
MDA
time frame: Before, middle and after CABG
GTX
time frame: Before ischemia, after ischemia, after reperfusion
SOD
time frame: Before ischemia, after ischemia, after reperfusion

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
Principal investigator Hossein Babaei, Pharm D, PhD
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)
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Tabriz University.