Comparative study of clinical outcomes of methylprednisolone and dexamethasone in prime solution during cardiopulmonary pump after coronary artery bypass grafting in patients candidate for bypass surgery
Comparative study of clinical outcomes of methylprednisolone and dexamethasone In prime solution during cardiopulmonary pump after coronary artery bypass grafting
Design
A randomized, controlled, double-blind with parallel groups
Settings and conduct
In this study, which will be conducted in the heart operating room of Chamran hospital in Isfahan, 62 patients undergoing coronary artery bypass surgery will enroll. Methylprednisolone and dexamethasone will be randomly used in the prime solution during cardiopulmonary pump to evaluate the duration of mechanical ventilation, days of hospitalization, bleeding, arrhythmia and inotrope intake.Participants in this study will be unaware of the type of drug being administered and analyzer will analyze the data as a code.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients undergoing coronary artery bypass grafting surgery, Consent to participate in the study
Non-inclusion criteria: History of valve surgery, Less than 40 years old and over than 60 years old, Ejection fraction less than 40%
Intervention groups
Intervention group 1: Methylprednisolone in prime solution during cardiopulmonary pump
Intervention group 2: Dexamethasone in prime solution during cardiopulmonary pump
Main outcome variables
Duration of mechanical ventilation, days of hospitalization, bleeding, arrhythmia, Inotrope intake
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170620034666N2
Registration date:2019-09-24, 1398/07/02
Registration timing:registered_while_recruiting
Last update:2019-09-24, 1398/07/02
Update count:0
Registration date
2019-09-24, 1398/07/02
Registrant information
Name
Mehran Shahzamani
Name of organization / entity
Isfahan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 3670 1227
Email address
m.shahzamani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-31, 1398/05/09
Expected recruitment end date
2020-02-28, 1398/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of clinical outcomes of methylprednisolone and dexamethasone in prime solution during cardiopulmonary pump after coronary artery bypass grafting in patients candidate for bypass surgery
Public title
Comparison of the effect of methylprednisolone and dexamethasone in prime solution
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients undergoing coronary artery bypass grafting surgery
Consent to participate in the study
Exclusion criteria:
History of valve surgery
Less than 40 years old and over than 60 years old
Ejection fraction less than 40%
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The random number table and block randomization method will be used using http://www.randomizer.org.In this method, eligible patients are divided into blocks of 4 patients. We create random numbers using computer.Based on the determined numerical range to enter individuals in each group, half of the patients in each block will receive methylprednisolone and half of them receive dexamethasone.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in this study will be unaware of the type of drug being administered and analyzer will analyze the data as a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Chamran hospital, Salman Farsi Blv, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-07-27, 1398/05/05
Ethics committee reference number
IR.MUI.MED.REC.1398.225
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft surgery
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass graft and biological heart valve graft
Primary outcomes
1
Description
Bleeding
Timepoint
After surgery
Method of measurement
Observation
2
Description
Hospitalization days
Timepoint
At the time of discharge
Method of measurement
Based on the day
3
Description
Inotrope intake
Timepoint
After the surgery
Method of measurement
Based on the recorded checklist
4
Description
Duration of mechanical ventialtion
Timepoint
At the time of discharge
Method of measurement
Based on the hour
5
Description
Arrhythmia
Timepoint
Continuously until discharge from cardiac intensive care unit
Method of measurement
Electrocardiogram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In dexamethasone group, 8 mg dexamethasone (Iran Hormone Company) is used in the prime solution. In the first 24 hours after surgery, the patient receives 8 mg dexamethasone every 8 hours and in the second 24 hours after surgery every 8 hours 4 mg dexamethasone and it is discontinued after the third 24 hours.
Category
Treatment - Drugs
2
Description
Intervention group 2: In methylprednisolone group, 8 mg methylprednisolone (Iran Hormone Company) is used in the prime solution. In the first 24 hours after surgery, the patient receives 8 mg methylprednisolone every 8 hours and in the second 24 hours after surgery every 8 hours 4 mg methylprednisolone and it is discontinued after the third 24 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac surgery clinic of chamran heart center
Full name of responsible person
Mehran Shahzamani
Street address
Chamran hospital, Salman Farsi Blv, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3667 1832
Email
m.shahzamani@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Research department of Isfahan University of Medical Sciences
Street address
Hezar Jarib blvd, Isfahan
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
m.shahzamani@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mehran Shahzamani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Chamran hospital, Salman Farsi Blv, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3670 1227
Fax
+98 31 3670 1227
Email
m.shahzamani@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehran Shahzamani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Chamran hospital, Salman Farsi Blv, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3670 1227
Fax
+98 31 3670 1227
Email
m.shahzamani@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehran Shahzamani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Chamran hospital, Salman Farsi Blv, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3670 1227
Fax
+98 31 3670 1227
Email
m.shahzamani@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After finishing the study the data will be available
When the data will become available and for how long
After publishing the article
To whom data/document is available
Faculty menbers
Under which criteria data/document could be used
Contacting the scientist responsible by email causes the data to be used in order to use the data in scientific research such as meta-analysis or secondary analysis.
From where data/document is obtainable
Scientific responsible can provide the study data to academic researchers without the name of individuals
What processes are involved for a request to access data/document
Just forwarding email to scientific responsible of this trial is enough