Objective: The effect of adenosine in cold blood cardioplegia on cardiac function and ischemia- reperfusion injury in patients undergoing heart valve surgery
Design: This study is a double blind randomized clinical trial that involved all patients with mitral valve disease during year 2016.
Inclusion criteria: patients' willingness to participate in research; written informed consent; all of patients with mitral valve disease.
Exclusion criteria: patients with aortic valve disease; pulmonary disease; two valves diseases; coronary heart disease; liver disease; kidney disease; lung disease; high blood pressure; diabetes; asthma; heart surgery; cardiac output less than 30%; history of adenosine-sensitivity and all the patients had a previous surgical history.
Setting and conduct: 40 patients were randomly divided into two groups, after the heart-lung machine connected to the patient, cold blood cardioplegia solution (4 C °) injected into the aortic root anterograde (15 CC / Kg).
Interventions: To immobilize the heart in the control group hyperkalemic cardioplegic solution add and hyperkalemic cardioplegic solution with adenosine 2 mM will be used in the intervention group.
Main outcome measures variables: TNF- α, Troponin, LDH, CPK-mb , Ca
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061428454N1
Registration date:2016-07-20, 1395/04/30
Registration timing:prospective
Last update:
Update count:1
Registration date
2016-07-20, 1395/04/30
Registrant information
Name
Atefeh Asadmobini
Name of organization / entity
Kermanshah University of Medical Science, Cardiovascular Research Centre
Country
Iran (Islamic Republic of)
Phone
+98 83 3839 5970
Email address
aasadmobini@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
kermanshah university of medical science
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adenosine in cold blood cardioplegia on cardiac function and ischemia- reperfusion injery in patients undergoing heart valve surgery
Public title
The effect of adenosine in cardioplegic solution
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients' willingness to participate in research; written informed consent; all of patients with mitral valve disease.
Exclusion criteria: patients with aortic valve disease; pulmonary disease; two valves diseases; coronary heart disease; liver disease; kidney disease; lung disease; high blood pressure; diabetes; asthma; heart surgery; cardiac output less than 30%; history of adenosine-sensitivity and all the patients had a previous surgical history.
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
no
Secondary trial Id
no
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kermanshah University of Medical Science
Street address
Ethic committee, Vice chancellor for research, Building No. 2 Kermanshah University of Medical Sciences, Shaheed Beheshti Ave, Kermanshah
City
Kermanshah
Postal code
6715847134
Approval date
2016-02-17, 1394/11/28
Ethics committee reference number
KUMS.REC.13940367
Health conditions studied
1
Description of health condition studied
Mitral valve surgery
ICD-10 code
I05.8
ICD-10 code description
Mitral (valve) failure
Primary outcomes
1
Description
TNF-α
Timepoint
Before and after the intervention.
Method of measurement
Laboratory analysis of blood samples
Secondary outcomes
1
Description
Hemodynamic parameters
Timepoint
1. Basic 2-15 minutes after CPB 3-6 hours after CPB 4-24 hours after CPB
Method of measurement
Heart rhythm ECG, Blood pressure by artelain, CVP transducer dome
Intervention groups
1
Description
In order to immobilize the heart in the intervention group, hyperkalemic cardioplegic solution with adenosine 2 mM will be used in the intervention group.
Category
Treatment - Surgery
2
Description
In order to immobilize the heart hyperkalemic cardioplegic solution will be used in the control group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Dr Feridoun Sabzi
Street address
Imam Ali Hospital, Shaheed Beheshti Ave, Kermanshah, Iran
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behrooz Hamzeh
Street address
Vice Chancellor for Research, Kermanshah University of Medical Sciences, Shaheed Beheshti Ave, Kermanshah
City
Kermanshah
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, Kermanshah 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
Cardiovascular Research Centre, Imam Ali Hospital, Kermanshah, Iran
Full name of responsible person
Atefeh Asadmobini
Position
Researcher
Other areas of specialty/work
Street address
Cardiovascular Research Centre, Imam Ali Hospital, Shaheed Beheshti Ave, Kermanshah, Iran
City
Kermanshah
Postal code
6715847145
Phone
+98 83 3839 5970
Fax
Email
a.asadmobini@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cardiovascular Research Center, Kermanshah University of Medical Science, Kermanshah, Iran
Full name of responsible person
Dr Feridoun Sabzi
Position
Cardiac surgeon
Other areas of specialty/work
Street address
Cardiovascular Research Centre, Imam Ali Hospital, Shaheed Beheshti Ave, Kermanshah, Iran
City
Kermanshah
Postal code
6715847145
Phone
+98 83 3839 5970
Fax
+98 83 3839 5970
Email
Dr_sabzi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Cardiovasclar Research Center, Kermanshah University of Medical Science
Full name of responsible person
Atefeh Asadmobini
Position
Researcher
Other areas of specialty/work
Street address
Cardiovascular Research Centre, Imam Ali Hospital, Shaheed Beheshti Ave, Kermanshah, Iran.
City
Kermanshah
Postal code
6715847145
Phone
+98 83 3839 5970
Fax
+98 83 3839 5970
Email
a.asadmobini@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)