Effect of selenium added to the cardioplegic solution on cardiac protection in coronary artery bypass grafting surgeries And the comparison with the control group
Effect of selenium added to the cardioplegic solution on cardiac protection in coronary artery bypass grafting surgeries And the comparison with the control group
Design
In this double blind clinical trial, 66 patients were divided into control and intervention groups. The patients were allocated to the groups using random numbers table.
Settings and conduct
This study was performed on heart surgery centers in Shiraz. Patients undergoing coronary artery bypass graft surgery were enrolled and the investigator and patients did not know how to intervene..
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients undergoing coronary artery bypass Grafting surgery and referring to Shiraz state hospitals ؛
EF more than 30%.
Exclusion Criteria:
Pregnancy ؛ Combined or re-surgical procedures
Intervention groups
In the intervention group, 1000 micrograms of selenium (sodium selenite) in 20 cc volume was added to the cardioplegic solution and the control group, the same volume of normal saline was added to the cardioplegia solution.
Main outcome variables
Cardiac Troponin level; Arrhythmia; Post operative Drug and DC shock use; IntraAortic Ballon Pump usage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180422039383N1
Registration date:2019-01-26, 1397/11/06
Registration timing:retrospective
Last update:2019-01-26, 1397/11/06
Update count:0
Registration date
2019-01-26, 1397/11/06
Registrant information
Name
Masoud Abasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3226 1707
Email address
masooda1361@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-21, 1396/03/31
Expected recruitment end date
2017-09-11, 1396/06/20
Actual recruitment start date
2017-07-06, 1396/04/15
Actual recruitment end date
2017-11-11, 1396/08/20
Trial completion date
empty
Scientific title
Effect of selenium added to the cardioplegic solution on cardiac protection in coronary artery bypass grafting surgeries And the comparison with the control group
Public title
Study of the effect of selenium on myocardial protection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Company satisfaction in research design
EF more than 30%
Age over 35 and under 80
Patients referred to the heart surgery room for CABG operation in government hospitals affiliated to Shiraz University of Medical Sciences.
Exclusion criteria:
Combination and redo surgery
History of recent infarction (less than a week)
pregnancy
High troponin level (greater than 3μgl / lit /)
Age
From 35 years old to 79 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
66
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into control and intervention groups using random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients did not have any information about the type of intervention and the intervention was performed during anesthesia and no information was given to the patient prior to anesthesia. And the information is completed by caregivers. After collecting information by a caregiver, this information is analyzed by a statistic expert.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
the central building of Shiraz University of Medical Sciences, in front of the Felestine Street, Zand street, Shiraz.
City
shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2017-06-03, 1396/03/13
Ethics committee reference number
ir.sums.rec.1396.49
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Graft Surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cardiac Troponin marker: The most specific marker for heart damage.
Timepoint
Troponin: at pre-operative intervals, immediately after surgery, 6 and 24 hours after surgery.
Method of measurement
Troponin: Vidas Laboratory tool
2
Description
Arrhythmia :It is called a disturbance in the normal rhythm of the heart and a symptom of a disorder in the normal functioning of the heart.
Timepoint
From the de-clamping of aorta until the patient is delivered to the ICU.
Method of measurement
Monitoring of arrhythmias using cardiac monitoring and eye care.
3
Description
Drug use and DC shock: The use of medication and DC shock indicates the severity of the risk and the risk of arrhythmia, which can be studied by comparing it in two groups.
Timepoint
From the de-clamping of aorta until the patient is delivered to the ICU.
Method of measurement
Through observation and review of the doctor's order in the patient file documents.
4
Description
Intra Aortic Ballon Pump : In a condition, the contractile power of the heart is not sufficient is used and increases the contractile power of the heart.
Timepoint
After weaning of cardiopulmonary pump.
Method of measurement
Doctor's order.Patient File Documentation.
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Before the operation, During the Cardiopulmonary Bypass, after cardiopulmonary bypass.
Method of measurement
Arterial Line
Intervention groups
1
Description
Intervention group: Adding 1000 microgram Selenium (Sodium selenite) to Cardioplegic Solution. The cardiopulmonary solution is then injected into the coronary arteries.
Category
Treatment - Drugs
2
Description
Control group: Adding 20 cc normal saline to cardioplegic solution. The cardiopulmonary solution is then injected into the coronary arteries.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Masood Abasi
Street address
Namazi Hospital,Namazi Square,Zand Blvd
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4332
Email
Nemazee_inf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sayed basir hashemi
Street address
In front of the Felestine Street, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 2559
Email
president@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masih Shafa
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Opposite the Palestine Street, Zand Street,Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
masooda1361@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masih Shafa
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Namazi hospital, Namazi square, Zand Street
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4332
Email
masooda1361@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masih Shafa
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Namazi Hospital, Namazi Square, Zand street
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4332
Email
masooda1361@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available