Objective: to determine the effect of vitamin C in high doses on myocardial injury and cardiac enzyme levels in the patients undergoing open heart surgery.
Study design: Randomized double-blind, Clinical Trial.
Inclusion criteria: Patients undergoing CABG, completed consent form.
Exclusion criteria: history of preoperative arrhythmia; heart ejection fraction less than 30%; severe renal or hepatic failure; pacemaker, permanent or temporary, treatment with anti-arrhythmic drugs and digoxin; some degree of AV block or bradycardia with a heart rate less than 50 min; a history of recent myocardial infarction (less than one month); high initial troponin levels (> 0.3 macro gram per liter), re-operation (redo) or complex (valve replacement + CABG).
Intervention: 40 patients undergoing open heart surgery were divided into two groups. Patients in Group A received five grams of vitamin C intravenously before induction of anesthesia and five grams of vitamin C in cardioplegia solution. Group B is considered as control group and received the same amount of a placebo.
Arterial blood samples will be taken to determine the serum levels of CPK-MB, Troponin I, LDH at the following intervals: induction, termination of cardiopulmonary bypass, 6 hours after the procedure, 24 hours of operation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016053019470N33
Registration date:2016-08-15, 1395/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-15, 1395/05/25
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Science
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high dose vitamin C on biochemical markers of myocardial injury in coronary artery bypass surgery
Public title
The effect of vitamin C on myocardial injury in coronary artery bypass surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing CABG, completed consent form.
Exclusion criteria: history of preoperative arrhythmia; heart ejection fraction less than 30%; severe renal or hepatic failure; pacemaker, permanent or temporary, treatment with anti-arrhythmic drugs and digoxin; some degree of AV block or bradycardia with a heart rate less than 50 min; a history of recent myocardial infarction (less than one month); high initial troponin levels (> 0.3 macro gram per liter), re-operation (redo) or complex (valve replacement + CABG).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
block randomization.com was used for randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiaz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.SUMS.Med.RED.1395.24
Health conditions studied
1
Description of health condition studied
coronary arthery heart disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
to determine the serum levels of CPK-MB, Troponin I, LDH
Timepoint
at the induction, termination of cardiopulmonary bypass, 6 hours after the procedure, 24 hours of operation
Method of measurement
Arterial blood samples
Secondary outcomes
empty
Intervention groups
1
Description
Patients in Group A received five grams of vitamin C intravenously before induction of anesthesia and five grams of vitamin C in cardioplegia solution
Category
Treatment - Drugs
2
Description
Group B is considered as control group and received the same amount of a placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
MRI Hospital
Full name of responsible person
Nafiseh Emadi
Street address
MRI Hospital, Chamran BLV.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiaz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences ,Zand streetl
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nafiseh Emadi
Position
Perfusionist
Other areas of specialty/work
Street address
Anesthesiology Department- Faghihi Hospital- Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
n.emadi66@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Elahe Alahyari
Position
Anesthesilogist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
allahyarye@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz anesthesiology and critical care research center
Full name of responsible person
Farzaneh Masihi
Position
English Consultant
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Research Tower, 5 th floor, Khalili street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)