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The effect of aortic root injection of adenosine on myocardial protection in patients undergoing coronary artery bypass surgery

Protocol summary

Summary
Objective: To investigate the effect of aortic root injection of adenosine on myocardial protection in patients undergoing coronary artery bypass graft surgery Study design: double blinded randomized clinical trial. Inclusion Criteria All CAD patients candidate for coronary artery bypass surgery( CABG) in Shiraz hospitals; completing the consent form for participation in the study. Exclusion criteria: Ejection Fraction less than 40%; over 70 years of age; using a balloon pump (IABP); receiving preoperative inotrope; redo –surgeries; combined surgery; emergency surgery; pulmonary disease; chronic atrial fibrillation; chronic arrhythmia treatment. Methods: 52 patients are divided into two groups of 26patients. After sternotomy and grafting , cannulation is performed. Aorta is clamped, 12 mg adenosine is injected through the cardiopulmonary cannula and cold blood cardioplegia solution with antigrad method will be injected. And in the control group (B), they receive the same amount of placebo before the injection of the cardioplegia solution. The cardiac immobilization time from the onset of cardioplegia solution injection to cardiac asystol will be recorded. After aortic declamping, we record the momentum of the beat of the heart. Arterial blood samples are taken for determining the serum level of CPK-MB enzymes, troponin I, at the induction of anesthesia 6, 12, and 24 hours after surgery. Arrhythmia, type and dose of inotropes, homodynamic changes (systolic and diastolic pressure, mean arterial pressure) heart rate, and mechanical ventilation time at 6 and 24 hours after surgery will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017013019470N51
Registration date: 2017-08-08, 1396/05/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-08, 1396/05/17
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research , Shiraz University of Medical Sciences
Expected recruitment start date
2017-08-02, 1396/05/11
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aortic root injection of adenosine on myocardial protection in patients undergoing coronary artery bypass surgery
Public title
The effect of aortic root injection of adenosine on myocardial protection in patients undergoing coronary artery bypass surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria All CAD patients candidate for coronary artery bypass surgery( CABG) in Shiraz hospitals; completing the consent form for participation in the study. Exclusion criteria: Ejection Fraction less than 40%; over 70 years of age; using a balloon pump (IABP); receiving preoperative inotrope; redo –surgeries; combined surgery; emergency surgery; pulmonary disease; chronic atrial fibrillation; chronic arrhythmia treatment.
Age
To 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2016-09-25, 1395/07/04
Ethics committee reference number
IR.SUMS.REC.1395.116

Health conditions studied

1

Description of health condition studied
Coronary Artery Bypass Surgery
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
the serum level of CPK-MB enzymes, troponin I
Timepoint
at the induction of anesthesia 6, 12, and 24 hours after surgery
Method of measurement
Arterial blood sample

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 12 mg adenosine is injected through the cardiopulmonary cannula and cold blood cardioplegia solution with antigrad method will be injected.
Category
Treatment - Drugs

2

Description
control group: Patients will be taken 5 cc normal saline before the injection of the cardioplegia solution.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hoptioal
Full name of responsible person
Behrooz Moslemi
Street address
Namazi Hoptioal, Namazi Square
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Behrooz Moslemi
Position
Nurse
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Universiy of Medical Sciences
Full name of responsible person
Shahrbano Shahbazi
Position
Cardio-anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
shahbazi.sh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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