Protocol summary
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Study aim
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Effect of Propofol Cardioplegia Solution on Myocardial Injury Bio marker in Coronary Artery Bypass Grafting Surgery
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Design
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Double Blinded Randomized Clinical Trial; sample size: 120 case; clinical phase: 2-3
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Settings and conduct
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Namazi and alzahra heart Hospital
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients who are undergoing elective CABG.
Exclusion criteria: Redo operation; emergency CABG for threatened myocardial infarction; Primary troponin level above 3 μg /L; severe renal failure; severe liver failure; congestive heart failure grade IV; Ejection fraction lower than 30%; Food Allergy ( eggs, soy, peanuts).
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Intervention groups
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Intervention group: Patients in the intervention group received 1200 μg / min propofol by syringe pump as a cardioplegic solution.
Control group: Patients in the control group received cardioplegic solution without adding propofol.
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Main outcome variables
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serum level of troponin I; serum level of CPKMB
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180922041084N2
Registration date:
2019-01-06, 1397/10/16
Registration timing:
prospective
Last update:
2019-01-24, 1397/11/04
Update count:
1
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Registration date
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2019-01-06, 1397/10/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-02-26, 1397/12/07
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Expected recruitment end date
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2019-05-28, 1398/03/07
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Propofol Cardioplegia Solution on Myocardial Injury Bio marker in Coronary Artery Bypass Grafting Surgery
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Public title
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Effect of Propofol Cardioplegia Solution on Myocardial Injury Bio marker
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patient who are candidate for elective Coronary Artery Bypass surgery
Exclusion criteria:
Redo surgery
Primary troponin level is above 3 μg / L
sever Renal failure
sever Liver failure
congestive Heart Failure grade IV
Ejection fraction lower than 30%
Allergy to eggs, soy, peanuts
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Age
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From 30 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients were randomized according to the charts which was derived from www.randomization.com site.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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A nurse who is unaware of the study groups will provide the cardioplegic solution and will deliver
cardioplegic solution to the nurse responsible for anesthesia for injection.The investigators in the operation room and in the ward are unaware of the study groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-08-23, 1397/06/01
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Ethics committee reference number
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IR.SUMS.REC.1397.415
Health conditions studied
1
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Description of health condition studied
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atherosclerosis
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ICD-10 code
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I25.1
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ICD-10 code description
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Atherosclerotic heart disease
Primary outcomes
1
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Description
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serum level of troponin I
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Timepoint
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1st sample just after induction ,2nd sample just after chest closure , 3rd sample 6 hours after arrival to ICU and last sample 24 hours after arrival to the ICU
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Method of measurement
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Lab test
2
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Description
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serum level of CPKMB
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Timepoint
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1st sample just after induction ,2nd sample just after chest closure , 3rd sample 6 hours after arrival to ICU and last sample 24 hours after arrival to the ICU
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Method of measurement
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Lab test
Secondary outcomes
1
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Description
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Arhytmia
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Timepoint
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During operation and after that
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Method of measurement
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Monitoring
Intervention groups
1
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Description
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Intervention group:Patients in the intervention group received 1200 μg / min propofol by syringe pump as a cardioplegic solution.
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Category
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Prevention
2
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Description
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Control group: Patients in the control group received cardioplegic solution without adding propofol .
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available