CABG-Induced Oxidative StressNCT00839085
Comparison of Ascorbic Acid and Grape Seed Extract in Oxidative Stress Induced by on Pump Heart Surgery
A study testing GSE and Vit C (Ascorbic Acid) in people with CABG-Induced Oxidative Stress, run by Tabriz University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CABG-Induced Oxidative Stress
- What is being tested?
- GSE and Vit C (Ascorbic Acid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIran
- Study dates
- Nov 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Candidates for elective CABG surgery with pump for first time
- 3VD
Who cannot join
- High risk patients
- Those who need another heart surgery beside CABG
- Urgent patients
- Diabetics
- Ischemic time more than 120 min
Trial locations and contacts
1 site in 1 country.
Iran1 site
Cardiovascular Research Center
Tabriz, East Azerbaijan Province, 51656-65811
About this study
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
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.
Read the 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)
- Conditions
- CABG-Induced Oxidative Stress
- Being tested
- GSE, Vit C (Ascorbic Acid)
- Keywords
- CABG, on pump, Grape seed extract, Vit C, Oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSEDrug
Also called Grape Seed Extract
grape seed extract (100 mg/6h), PO
Vit C (Ascorbic Acid)Drug
Also called Ascorbic Acid
Vit C 25 mg/ kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | normal procedure of CABG |
| 2: GSE | Active comparator | 100 mg GSE every 6h /Po, starting one day before surgery (4 doses in 24h) Receives: Drug: GSE |
| 3: Vit C | Active comparator | 25 mg/kg through pump Receives: Drug: Vit C (Ascorbic Acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVEF
Measured: Before and after CABG
Secondary outcomes (4)
Total Antioxidant Capacity (TAC)
Measured: Before ischemia, after ischemia, after reperfusion
MDA
Measured: Before, middle and after CABG
GTX
Measured: Before ischemia, after ischemia, after reperfusion
SOD
Measured: Before ischemia, after ischemia, after reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionJan 2009 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABG-Induced Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
- Investigators
- Hossein Babaei, Pharm D, PhD, Principal investigator, Drug Applied Research Center, Tabriz Univ Med SciNaser Safaei, MD, Surgeon, Study chair, Tabriz Univ Med SciMasood Pezaeshkian, MD, Principal investigator, Tabriz Univ Med SciAlireza Yaghobi, MD, Principal investigator, Tabriz Univ Med SciAhmad Reza Jodati, MD, Principal investigator, Tabriz Univ Med SciHossein Babaei, Pharm D, PhD, Study director, Tabriz Univ Med SciRasoul Azarfarin, MD, Principal investigator, Tabriz Univ Med SciMohammad Ali Sheikhalizadeh, CCP, Study director, Tabriz Univ Med Sci
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839085
- Sponsor's protocol ID
- 8710
- Status last verified
- Feb 2009
- First submitted
- 6 Feb 2009
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00839085
- Acronym / sponsor ID
- 8710
- Conditions
- CABG-Induced Oxidative Stress
- Keywords
- CABG, on pump, Grape seed extract, Vit C, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 9 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –normal procedure of CABG |
| 2: GSE | Active comparator | Drug: GSE100 mg GSE every 6h /Po, starting one day before surgery (4 doses in 24h) |
| 3: Vit C | Active comparator | Drug: Vit C (Ascorbic Acid)25 mg/kg through pump |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Candidates for elective CABG surgery with pump for first time
- 3VD
Key exclusion criteria (5 listed)
- High risk patients
- Those who need another heart surgery beside CABG
- Urgent patients
- Diabetics
- Ischemic time more than 120 min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSEAlso: Grape Seed Extractgrape seed extract (100 mg/6h), PO | Drug | 2: GSE |
| Vit C (Ascorbic Acid)Also: Ascorbic AcidVit C 25 mg/ kg | Drug | 3: Vit C |
Primary outcome
LVEF
Time frame: Before and after CABG
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hossein Babaei, Pharm D, PhD principal investigator
Drug Applied Research Center, Tabriz Univ Med Sci
Naser Safaei, MD, Surgeon study chair
Tabriz Univ Med Sci
Masood Pezaeshkian, MD principal investigator
Tabriz Univ Med Sci
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GSE and Vit C (Ascorbic Acid) in people with CABG-Induced Oxidative Stress, run by Tabriz University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LVEF (time frame: Before and after CABG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2009.