The aim of this study was to determine the effect of vitamin C on inflammatory markers and hemodynamic parameters in patients undergoing coronary artery bypass surgery on the heart center of Bushehr. So that if the drug reduces inflammatory markers, and have beneficial effects on hemodynamic parameters It can be as a safe and low-cost drugs to reduce the side effects of the inflammatory response induced by cardiopulmonary bypass can be used. Inclusion criteria: patients undergoing elective surgery and Exclusion criteria: drug reaction and any problems during surgery.This study is a randomized, controlled clinical trial with 80 male and female patients 18 years and older undergoing CABG surgery with cardiopulmonary bypass. The samples were block randomly assigned to either an experimental group and control blocks (40 patients in each group) are divided. For intervention to patients in the experimental group received 2 grams of vitamin C (4 ampoules 5CC) intravenously 10 minutes after induction of anesthesia and the patients in the control group normal saline solution of 4 ampules 5 CC at the same time for intravenous injection will be. Blood samples were collected before the intervention and the end of 10 minutes and 24 hours after cardiopulmonary bypass surgery artery catheter to determine the amount of IL-6 and hsCRP and in the laboratory using enzyme-linked immunodeficient will be measured. The hemodynamic parameters measured at the same time the blood sample and will be registered in the check- list.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120922466N10
Registration date:2016-06-13, 1395/03/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-13, 1395/03/24
Registrant information
Name
Shahnaz Pouladi
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 374 0061
Email address
sh.pooladi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of vitamin C on inflammatory markers and hemodynamic parameters in patients undergoing Coronary Artery Bypass Surgery
Public title
The effect of vitamin C on inflammatory markers and hemodynamic parameters in patients undergoing coronary artery bypass surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria included patients undergoing elective coronary artery bypass graft surgery with cardiopulmonary bypass, aged between 40 and 80 years, at the same time non-malignant disease, no history of hypersensitivity reactions, patients with atrial fibrillation admitted lack of experience, lack of large trauma or major surgery less than 6 months of surgery, lack of ejection fraction less than 30%, not having kidney failure. Exclusion criteria: drug reaction and any problems with anesthesia during surgery, atrial fibrillation during operation.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Bushehr, sabz abad, Salman Farsi Avenue, Bushehr university of Medical Science, pardis site.
City
Busheher
Postal code
Approval date
2016-05-16, 1395/02/27
Ethics committee reference number
IR.BPUMS.REC.1395.31
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Surgery
ICD-10 code
T82.9
ICD-10 code description
T82.9 Unspecified complication of cardiac and vascular prosthetic device, implant and graft
Primary outcomes
1
Description
Inflammatory markers (interleukin 6 and hsCRP)
Timepoint
10 minutes before the intervention and after the intervention (the end of CPB and 24 hours after surgery.
Method of measurement
Using the method of testing and enzyme-linked immunosorbent
2
Description
Hemodynamic parameters
Timepoint
10 minutes before the intervention and after the intervention (the end of CPB and 24 hours after surgery.
Method of measurement
check- list
Secondary outcomes
1
Description
Gastrointestinal side effects
Timepoint
A week after intervention and at the end of intervention
Method of measurement
Visual
Intervention groups
1
Description
Intervention group: 2 grams of Vitamin C (4 ampoules 5 ml) intravenously 10 minutes after induction of anesthesia
Category
Treatment - Drugs
2
Description
Control group:normal saline solution Equivalent
4 ampoules 5 ml intravenously 10 minutes after induction of anesthesia
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart Center of Bushehr
Full name of responsible person
Parisa Eskandari, Graduate Student in Nursing
Street address
Bushehr, Moalem street
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medical Sciences Bushehr, Vice chancellor for research
Full name of responsible person
Dr. Afshin Ostovar
Street address
Bushehr, Sabz abad, Salman Farsi Avenue, Bushehr university of Medical Science,Pardis Site.
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Sciences Bushehr, Vice chancellor for research
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
Bushehr University of Medical Sciences
Full name of responsible person
Shahnaz Pouladi
Position
Assistant professor
Other areas of specialty/work
Street address
Bushehr, Sabz abad, Salman Farsi Avenue, Bushehr university of Medical Sciences, Pardis Site.
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Fax
+98 77 3345 2228
Email
Research(AT) Bpums.Ac.Ir; Sh.pooladi@bpums.ac.ir
Web page address
www.bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Shahnaz Pouladi
Position
Assistant Professor
Other areas of specialty/work
Street address
Bushehr, sabz abad, Salman Farsi Avenue, Bushehr university of Medical Sciences, pardis site.
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Fax
+98 77 3345 2228
Email
Research(AT) Bpums.Ac.Ir; Sh.pooladi@bpums.ac.ir
Web page address
www.bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Shahnaz Pouladi
Position
Assistant Professor
Other areas of specialty/work
Street address
Bushehr, Sabz Abad, Salman Farsi Avenue, Bushehr University of Medical Sciences, Pardis Site.
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Fax
+98 77 3345 2228
Email
Research(AT) Bpums.Ac.Ir; Sh.pooladi@bpums.ac.ir
Web page address
www.bpums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)