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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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History
# Registration date Revision Id
4 2021-03-24, 1400/01/04 176331
3 2021-01-26, 1399/11/07 169518
2 2020-10-18, 1399/07/27 162171
1 2019-07-26, 1398/05/04 98129
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  • Protocol summary

    Having surgery just by coronary artery bypass Left ventricular Ejection fraction between 45-60% Left ventricle end diastole Diameter (LVEDD) less than 60 mm pump time less than 180 minutes Cross Clamp Aorta time less than 90 minutes
    Having surgery just by coronary artery bypass Left ventricular Ejection fraction between 45-60% Left ventricle end-diastole Diameter (LVEDD) less than 60 mm
    داشتن عمل جراحی صرفا بای پس عروق کرونری کسر تخلیه ای بین 45 تا 60درصد قطر دیواره بطن چپ در پایان دیاستول(LVEED) کمتر از 60 میلی متر طول پمپ تایم کمتر از 180 دقیقه طول کلامپ آئورت کمتر از 90 دقیقه
    داشتن عمل جراحی صرفا بای پس عروق کرونری کسر تخلیه ای بین 45 تا 60درصد قطر دیواره بطن چپ در پایان دیاستول(LVEED) کمتر از 60 میلی متر

  • General information

    300
    280
    275
    280
    Having surgery just by coronary artery bypass
    Left ventricular Ejection fraction between 45-60%
    Left ventricle end diastole Diameter (LVEDD) less than 60 mm
    Pump time less than 180 minutes
    Cross Clamp Aorta time less than 90 minutes
    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)
    داشتن عمل جراحی صرفا بای پس عروق کرونری
    کسر تخلیه ای بین 45 تا 60درصد
    قطر دیواره بطن چپ در پایان دیاستول(LVEED) کمتر از 60 میلی متر
    طول پمپ تایم کمتر از 180 دقیقه
    طول کلامپ آئورت کمتر از 90 دقیقه
    داشتن عمل جراحی بای پس عروق کرونری به دلیل بیماری عروق کرونر و آترواسکلروز
    کسر تخلیه ای بین 45 تا 60درصد
    قطر دیواره بطن چپ در پایان دیاستول(LVEED) کمتر از 60 میلی متر
    سن بالاتر 18 سال
    نداشتن دیابت و عدم مصرف کننده داروهای ضد دیابت
    نداشتن بیماری سیستمیک جدید از قبیل مشکلات ریوی، کبدی، کلیوی، مشکلات اسکلتی-عضلانی، ایمنی
    عدم شرکت در مطالعات دیگر
    عدم داشتن هرگونه آریتمی یا عدم مصرف داروی ضد آریتمی (به جز بتابلاکر)
    History of previously inappropriate reaction to Esmolol
    Prescribing Esmolol over the past 30 days
    Emergency operation
    Participate in other studies
    any confirmed arrhythmia or consuming any anti-arrhythmic agents
    severe systemic diseases (including any pulmonary, hepatic, renal, and musculoskeletal diseases or immune system illnesses)
    diabetic patients consuming any oral hypoglycemic agents
    reduction of heart rate to less than 50 beats per minute or systolic blood pressure to less than 90 mmHg when injecting esmolol during the surgery
    pumping time > 120 minutes
    aortic cross-clamping > 90 minutes
    intra-operative patient’s death
    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
    سابقه واکنش نامناسب قبلی به اسمولول
    تجویز اسمولول طی 30 روز گذشته
    عمل اورژانسی
    شرکت در مطالعات دیگر
    داشتن هرگونه آریتمی یا داروی ضد آریتمی
    بیماری سیستمیک جدید از قبیل مشکلات ریوی، کبدی، کلیوی، مشکلات اسکلتی-عضلانی، ایمنی
    بیماران دیابتی و مصرف کننده داروهای ضد دیابت
    کاهش ضربان قلب به زیر 50 و فشار خون سیستولی به زیر 90 پس از تزریق اسمولول
    زمان پمپ > 120 دقیقه
    زمان کلامپ آئورت > 90 دقیقه
    مرگ بیمار حین عمل
    عدم تمایل بیمار به شرکت در مطالعه
    عدم نیاز به عمل اورژانسی
    نداشتن سابقه واکنش نامناسب قبلی به اسمولول
    عدم تجویز اسمولول طی 30 روز گذشته
    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 2, the sufficient and estimated sample size will be 300, 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.
    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.
    بیماران با استفاده از روش تصادفی بلوک بدون لایه بندی به دو گروه مداخله یا گروه کنترل تقسیم خواهند شد تا نسبت تصادفی یکنواخت (1:1) حفظ شود. متخصص آمار مرکز که نسبت به طرح و فرآیند انتخاب بیماران آن آگاهی نداشته از نرم افزار تولیدکننده توالی تصادفی (Random Allocation Software) برای تعیین گروه ها استفاده خواهد کرد. برای کار با این نرم افزار سایز هر بلوک مساوی و برابر 2 در نظر گرفته شد همچنین جهت کدهای تخصیص یافته به بیماران از حالت ترتیبی (sequential) استفاده می شود. سپس حجم نمونه به عنوان 300 انتخاب می گردد و از خروجی نرم افزار جهت ترتیب و گروه بیماران استفاده خواهد شد. پس از مشخص شدن لیست گروه بندی بیماران، کد بیماران بر روی پاکتهای نامه غیرشفاف نوشته خواهد شد و داخل آن برگه ای حاوی گروه مداخله یا کنترل نوشته می شود و همه ی 300 پاکتهای نامه در جعبه ی مخصوص قفل داری جهت نگهداری گذاشته خواهد شد و در اتاق مخصوص آنالیزور مرکز که کلید آن دست خود وی می باشد و هیچ پنجره ای روبه بیرون ندارد نگهداری می شود. از پاکتهای نامه به همان ترتیبی که بیماران به نوبت برای عمل مراجعه می کنند، استفاده خواهد شد.
    بیماران با استفاده از روش تصادفی بلوک بدون لایه بندی به دو گروه مداخله یا گروه کنترل تقسیم خواهند شد تا نسبت تصادفی یکنواخت (1:1) حفظ شود. متخصص آمار مرکز که نسبت به طرح و فرآیند انتخاب بیماران آن آگاهی نداشته از نرم افزار تولیدکننده توالی تصادفی (Random Allocation Software) برای تعیین گروه ها استفاده خواهد کرد. برای کار با این نرم افزار سایز هر بلوک مساوی و برابر 4 در نظر گرفته شد همچنین جهت کدهای تخصیص یافته به بیماران از حالت ترتیبی (sequential) استفاده می شود. سپس حجم نمونه به عنوان 280 انتخاب می گردد و از خروجی نرم افزار جهت ترتیب و گروه بیماران استفاده خواهد شد. پس از مشخص شدن لیست گروه بندی بیماران، کد بیماران بر روی پاکتهای نامه غیرشفاف نوشته خواهد شد و داخل آن برگه ای حاوی گروه مداخله یا کنترل نوشته می شود و همه ی 300 پاکتهای نامه در جعبه ی مخصوص قفل داری جهت نگهداری گذاشته خواهد شد و در اتاق مخصوص آنالیزور مرکز که کلید آن دست خود وی می باشد و هیچ پنجره ای روبه بیرون ندارد نگهداری می شود. از پاکتهای نامه به همان ترتیبی که بیماران به نوبت برای عمل مراجعه می کنند، استفاده خواهد شد.

  • Primary outcomes

    #1
    Measurement of biochemical markers of myocardial injury before and 12, 24 and 48 hours after surgery
    Measurement of biochemical markers of myocardial injury before and 4, 12, 24 and 48 hours after surgery
    اندازه گیری بیومارکرهای شیمیایی آسیب میوکارد 12-24-48 ساعت پس از عمل
    اندازه گیری بیومارکرهای شیمیایی آسیب میوکارد در 4-12-24-48 ساعت پس از عمل

  • Secondary outcomes

    #1
    Left ventricular ejection fraction at one week after the surgery
    empty
    کسر خروج بطن چپ در 1 هفته پس از عمل
    empty
    One week after the surgery
    empty
    1 هفته پس از عمل
    empty
    Echocardiography
    empty
    اکوکاردیوگرافی
    empty

  • Intervention groups

    #1
    The intervention group received esmolol hydrochloride (as 100 mg/10 ml vial, ESOCARD, SAMARTH life sciences PVT. LTD pharmaceutical Co. INDIA) during the operation twice. First, as a 2 mg/kg in central venous catheter just before starting the CPB. After 5 minutes, if the hemodynamic status was remained stable, the patient was put on CPB. Half of the first dose (1 mg/kg) was then infused with the cardioplegic solution after aortic cross-clamping. This dose was repeated for the next doses of the cardioplegic solution during the surgery.
    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.
    گروه مداخله: بیماران این گروه پس از القای بی هوشی و تعبیه لاین های وریدی مرکزی و شریانی ,مراحل عمل بصورت روتین انجام می گیرد. در زمانی که کانولاسیون وریدی در دهلیز راست و شریانی در شریان آئورت انجام می گیرد و بیمار آماده بای پس قلبی ریوی می شود داروی اسمولول هیدروکلرید (100mg/10cc) به میزان 2 میلی گرم به ازای هرکیلوگرم وزن بیمار از طریق کاتتر ورید مرکزی به صورت بلوس تزریق می گردد. در صورت عدم اختلال در شرایط همودینامیک بیمار پس از 5 دقیقه بیمار وارد بای پس می شود. پس از کلامپ آئورت در لاین کاردیوپلژی داروی اسمولول حین تزریق کاردیوپلژی این بار به میزان 1 میلی گرم به ازای هرکیلوگرم وزن بیمار تزریق می شود.
    گروه مداخله: بیماران این گروه پس از القای بی هوشی و تعبیه لاین های وریدی مرکزی و شریانی ,مراحل عمل بصورت روتین انجام می گیرد. در زمانی که کانولاسیون وریدی در دهلیز راست و شریانی در شریان آئورت انجام می گیرد و بیمار آماده بای پس قلبی ریوی می شود داروی اسمولول هیدروکلرید (100mg/10cc) به میزان 2 میلی گرم به ازای هر کیلوگرم وزن بیمار از طریق کاتتر ورید مرکزی به صورت بلوس تزریق می گردد. پس از 5 دقیقه بیمار وارد بای پس می شود. پس از کلامپ آئورت در لاین کاردیوپلژی داروی اسمولول حین تزریق کاردیوپلژی این بار به میزان 1 میلی گرم به ازای هرکیلوگرم وزن بیمار تزریق می شود. این مقدار برای دفعات بعدی کاردیوپلژی نیز تکرار خواهد شد.

Protocol summary

Study aim
Use of esmolol in the cardioplegic solution for reducing myocardial injury in patients with CABG
Design
randomized double-blinded placebo-controled clinical trial
Settings and conduct
Chamran Heart Complex of Isfahan Univerdsity of Medical Sciences
Participants/Inclusion and exclusion criteria
Having surgery just by coronary artery bypass Left ventricular Ejection fraction between 45-60% Left ventricle end-diastole Diameter (LVEDD) less than 60 mm
Intervention groups
esmolol in the cardioplegic solution for the intervention group and the routine cardioplegic solution for the control group.
Main outcome variables
Faster healing in patients undergoing cardiac surgery

General information

Reason for update
The trial protocol has been updated due to the investigator's wishes in order to improve the quality of trial design and conduction methodology.
Acronym
IRCT registration information
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
Registration date
2019-07-26, 1398/05/04
Registrant information
Name
Ehsan Rangraz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3521 1312
Email address
ehsanrangraz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-03, 1397/12/12
Expected recruitment end date
2020-05-03, 1399/02/14
Actual recruitment start date
2019-08-01, 1398/05/10
Actual recruitment end date
2020-09-30, 1399/07/09
Trial completion date
2020-10-30, 1399/08/09
Scientific title
The effect of Esmolol before cardioplegia and in the cardioplegic solution on the myocardial injury biomarkers in coronary artery bypass graft surgery patients
Public title
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
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 280
Actual sample size reached: 280
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
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
Hezar jerib Ave,isfahan university of Medical sciences
City
isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.MUI.MED.REC.1397.290

Health conditions studied

1

Description of health condition studied
coronary Artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
Average of cardiac biomarkers Troponin I, CK-MB and LDH
Timepoint
Measurement of biochemical markers of myocardial injury before and 4, 12, 24 and 48 hours after surgery
Method of measurement
Patient blood samples and laboratory measurements

Secondary outcomes

1

Description
Frequency of ventricular fibrillation during the heart re-beat
Timepoint
After unclamping the aorta
Method of measurement
Electrocardiogram

2

Description
hours of ICU stay
Timepoint
After the surgery
Method of measurement
hours documented in the charts

3

Description
Duration of patient admission after surgery in hospital
Timepoint
Number of hospital admission days in the post-operative
Method of measurement
Follow patient

4

Description
Need for inotropic drugs
Timepoint
Check the number of inotropes used
Method of measurement
Follow patient

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Ehsan Rangraz
Street address
Chamran Hospital, Salman farsi Ave , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8156166764
Phone
+98 31 3260 0961
Email
EhsanRangraz@yahoo.COM

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Rangraz
Street address
Isfahan univ.medical science Azadi
City
Isfahan
Province
Isfehan
Postal code
8156166764
Phone
+98 31 3521 1312
Email
EhsanRangraz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Chamran Hospital, Salman farsi Ave , Isfahan
City
isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3260 0961
Email
drshahzamani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehran Shahzamani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Chamran Hospital, Salman farsi Ave , Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3260 0961
Email
drshahzamani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Rangraz
Position
Master of science
Latest degree
Master
Other areas of specialty/work
Cardiology
Street address
Chamran Hospital, Salman farsi Ave , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8156166764
Phone
+98 31 3524 3409
Email
Ehsanrangraz@yahoo.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
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