Protocol summary
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Study aim
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The effect of adenosine in cold blood cardioplegia on cardiac function and ischemia- reperfusion injury in patients undergoing heart valve surgery
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Design
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This study is a double blind randomized clinical trial that involved all patients with mitral valve disease during year 2016
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Settings and conduct
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The study is being carried out at Shahid Rajaee Hospital.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).
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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TNF-α
General information
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Reason for update
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Change the location of the project
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016061428454N1
Registration date:
2016-07-20, 1395/04/30
Registration timing:
prospective
Last update:
2019-11-13, 1398/08/22
Update count:
1
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Registration date
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2016-07-20, 1395/04/30
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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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kermanshah university of medical science
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Expected recruitment start date
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2018-12-22, 1397/10/01
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Expected recruitment end date
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2019-12-22, 1398/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of adenosine in cold blood cardioplegia on cardiac function and ischemia- reperfusion injery in patients undergoing heart valve surgery
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Public title
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The effect of adenosine in cardioplegic solution
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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.
Exclusion criteria:
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Age
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From 30 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Forty patients were randomly divided into two groups and matched for severity of disease and compared in each group of patients with the same severity (stenosis, dilation, failure, repair and replacement).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The patient, surgeon, and physician responsible for evaluating the patient are not aware of the type of treatment
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Placebo
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Not 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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2018-04-28, 1397/02/08
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Ethics committee reference number
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IR-RHC-REC-1397-007
Health conditions studied
1
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Description of health condition studied
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Mitral valve surgery
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ICD-10 code
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I05.8
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ICD-10 code description
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Mitral (valve) failure
Primary outcomes
1
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Description
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TNF-α
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Timepoint
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Before and after the intervention.
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Method of measurement
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Laboratory analysis of blood samples
Secondary outcomes
1
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Description
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Hemodynamic parameters
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Timepoint
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1. Basic 2-15 minutes after CPB 3-6 hours after CPB 4-24 hours after CPB
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Method of measurement
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Heart rhythm ECG, Blood pressure by artelain, CVP transducer dome
Intervention groups
1
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Description
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In order to immobilize the heart in the intervention group, hyperkalemic cardioplegic solution with adenosine 2 mM will be used in the intervention group.
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Category
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Treatment - Surgery
2
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Description
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In order to immobilize the heart hyperkalemic cardioplegic solution will be used in the control group.
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Category
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Treatment - Surgery
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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Rajaee hospital
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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the data has been report as a article
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When the data will become available and for how long
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after data collection
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To whom data/document is available
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The data are available to the study researchers.
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Under which criteria data/document could be used
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The data are available to the study researchers.
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From where data/document is obtainable
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Rajaee Hospital
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What processes are involved for a request to access data/document
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Must be part of the research project.
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Comments
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