Protocol summary
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Study aim
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Use of esmolol in the cardioplegic solution for reducing myocardial injury in patients with CABG
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Design
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randomized double-blinded placebo-controled clinical trial
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Settings and conduct
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Chamran Heart Complex of Isfahan Univerdsity of Medical Sciences
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Participants/Inclusion and exclusion criteria
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Having surgery just by coronary artery bypass
Left ventricular Ejection fraction between 45-60%
Left ventricle end-diastole Diameter (LVEDD) less than 60 mm
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Intervention groups
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esmolol in the cardioplegic solution for the intervention group and the routine cardioplegic solution for the control group.
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Main outcome variables
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Faster healing in patients undergoing cardiac surgery
General information
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Reason for update
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The trial protocol has been updated due to the investigator's wishes in order to improve the quality of trial design and conduction methodology.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180428039456N1
Registration date:
2019-07-26, 1398/05/04
Registration timing:
prospective
Last update:
2021-03-26, 1400/01/06
Update count:
3
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Registration date
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2019-07-26, 1398/05/04
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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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2019-03-03, 1397/12/12
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Expected recruitment end date
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2020-05-03, 1399/02/14
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Actual recruitment start date
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2019-08-01, 1398/05/10
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Actual recruitment end date
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2020-09-30, 1399/07/09
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Trial completion date
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2020-10-30, 1399/08/09
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Scientific title
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The effect of Esmolol before cardioplegia and in the cardioplegic solution on the myocardial injury biomarkers in coronary artery bypass graft surgery patients
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Public title
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The effect of Esmolol before cardioplegia and as a combination in cardioplegia on biochemical markers of myocardial injury in patients undergoing coronary artery bypass graft surgery
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Only coronary bypass grafting surgery candidates due to coronary artery disease and atherosclerosis
Left ventricular Ejection fraction between 45-60%
Left ventricle end diastole Diameter (LVEDD) less than 60 mm
Age above 18 years old
Not having diabetes mellitus type 2 or consuming any oral hypoglycemic agents
Not having severe systemic diseases (including any pulmonary, hepatic, renal, and musculoskeletal diseases or immune system illnesses)
Not participating in any other studies
Not having any confirmed arrhythmia or consuming any anti-arrhythmic agents (except beta-blockers)
Exclusion criteria:
Not willing to participate in the study
No need for emergency operation
No history of inappropriate reaction to Esmolol
Not received Esmolol over the past 30 days
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Age
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No age limit
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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:
280
Actual sample size reached:
280
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients are allocated into either the intervention or control group using a non-stratified block randomization method to keep an even randomization ratio of (1:1). Random Allocation Software is used by our expert analytics to determine the list and group of patients. He is blinded to the selection process and pre- and post-operative assessments. The block size will be equal and is set to 4, the sufficient and estimated sample size will be 280, then the allocation code is set to sequential. The analytics will use the output of software to determine the sequence and allocation of patients. Then each code is written on a non-transparent envelope and a paper is put in it in which the intervention or control is written on the paper. The series of the envelope will be according to the software's list and they will keep in a large box with a locker. The analytics has the key for the box and this box will be kept in his room which the analytics has its only key and has no windows. As the patients enrolled in the study sequentially, the analytics use the designated envelope.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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All of the involved investigators and researchers, participants, principle surgeon, technician of cardiopulmonary bypass machine, anesthesiologist, and other operation room staff will not know which A or B is intervention or placebo group. Only the pharaceutical company which manufacture the ampule which is contaning the active drug or steril normal saline knows that.
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Placebo
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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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2019-03-03, 1397/12/12
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Ethics committee reference number
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IR.MUI.MED.REC.1397.290
Health conditions studied
1
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Description of health condition studied
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coronary Artery disease
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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 of native coronary artery
Primary outcomes
1
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Description
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Average of cardiac biomarkers Troponin I, CK-MB and LDH
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Timepoint
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Measurement of biochemical markers of myocardial injury before and 4, 12, 24 and 48 hours after surgery
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Method of measurement
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Patient blood samples and laboratory measurements
Secondary outcomes
1
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Description
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Frequency of ventricular fibrillation during the heart re-beat
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Timepoint
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After unclamping the aorta
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Method of measurement
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Electrocardiogram
2
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Description
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hours of ICU stay
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Timepoint
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After the surgery
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Method of measurement
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hours documented in the charts
3
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Description
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Duration of patient admission after surgery in hospital
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Timepoint
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Number of hospital admission days in the post-operative
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Method of measurement
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Follow patient
4
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Description
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Need for inotropic drugs
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Timepoint
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Check the number of inotropes used
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Method of measurement
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Follow patient
Intervention groups
1
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Description
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The intervention group receives esmolol hydrochloride (as 100 mg/10 ml vial, ESOCARD, SAMARTH life sciences PVT. LTD pharmaceutical Co. INDIA) during the operation. First, as a 2 mg/kg in central venous catheter just before starting the CPB. After 5 minutes, the patient will put on CPB. Half of the first dose (1 mg/kg) will then be infused with the cardioplegic solution after aortic cross-clamping. This dose will be repeated for the next doses of the cardioplegic solution during the surgery.
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group received the same volume of normal saline (10 mL) from an exact vial (manufactured in the Afachemi Pharmaceutical Co. IRAN).
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Category
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Placebo
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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Esfahan 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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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be 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