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
Use of osmolol before cardioplegia and as a cardioplegia to reduce myocardial injury
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
chamran Hospital
Participants/Inclusion and exclusion criteria
Having surgery just by coronary artery bypass
Age over 18 years
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
Intervention groups
the patient undergoing cabg
Main outcome variables
Faster healing in patients undergoing cardiac surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180428039456N1
Registration date:2019-07-26, 1398/05/04
Registration timing:retrospective
Last update:2019-07-26, 1398/05/04
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
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific 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
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
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having surgery just by coronary artery bypass
Age over 18 years
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
Exclusion criteria:
History of previously inappropriate reaction to Esmolol
Prescribing Esmolol over the past 30 days
Emergency operation
Participate in other studies
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient, nurse and drug instructor are not aware of the patient grouping.The surgeon, anesthesiologist and a researcher are aware of this grouping.
Placebo
Used
Assignment
Other
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
Increase rate of biochemical markers of myocardial injury contain Troponin,Cpk MB and LDH
Timepoint
Measurement of biochemical markers of myocardial injury before and 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 first rhythm after arrest with cardioplegia
Timepoint
Cardiac arrest period with cardioplegia
Method of measurement
Electrocardiogram
2
Description
Duration of admission to the intensive care unit
Timepoint
Number of hospital admissions days in post-operative care unit
Method of measurement
Follow patient
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
Intervention group: Patients in this group undergo routine operation following induction of anesthesia and insertion of central venous and arterial lines. after cannulation , when patient is ready for cardiopulmonary bypass, the osmolol hydrochloride (100mg / 10cc) dose of 2mg / kg of patient's weight through the central venous catheter is given as Plows are injected. In case of non-impairment of hemodynamic conditions, the patient undergoes a bypass after 5 minutes. After the aortic clamp in the cardioplegia line, osmolol inject during cardioplegia is injected at a dose of 1 mg per kg body weight. Other steps are routinely performed and the patient is monitored for one week.
Category
N/A
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
50
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