A Comparative Study on the Effect of Handmade Del Nido Cardioplegia Solution with Handmade St. Thomas Cardioplegia Solution in terms of Quantitative Levels of Cardiac Troponin I and Phosphocreatine kinase MB in Ventricular Septal Defect Repair in Pediatric Cardiac Surgery.
A Comparative Study on the Effect of Handmade Del Nido Cardioplegia Solution with Handmade St.
Thomas Cardioplegia Solution in terms of Quantitative Levels of Cardiac Troponin I and Phosphocreatine kinase MB in Ventricular Septal Defect Repair in Pediatric Cardiac Surgery.
Design
Randomized, parallel, and blind clinical trials.
Settings and conduct
Sixty patients under the age of 12 who were candidates for ventricular surgery in Chamran Hospital in Isfahan will be divided into two groups of 30 recipient recipients of St. Thomas and Del Nidou. A St. Thomas solution with a dose of 20 ml per kg and a temperature of 4 ° C and a Dilu Nido solution at a dose of 15 ml per kg and a ratio of four crystalloid units at 4 ° C and one unit of oxygenated oxygen in the patient is. Both solutions are surgically sterilized immediately before injection of cardioplegia solution and surgically injected through the syringe through a cardioplegia cannula inserted by the surgeon at the root of the aorta. Patients do not know their medication due to anesthesia during surgery.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Having less than 12 years of age
Obtaining informed consent written consent for all parents.
Exclusion Criteria:
Having a history of heart failure
Having a history of myocardial infarction.
Intervention groups
Thirty patients with St. Thomas and 30 patients will also receive a perfusionist hand-made cardiopulmonary dendritic solution.
Main outcome variables
The low level of troponin I, the level of phospho creatine kinase.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038142N8
Registration date:2019-03-16, 1397/12/25
Registration timing:registered_while_recruiting
Last update:2019-03-16, 1397/12/25
Update count:0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study on the Effect of Handmade Del Nido Cardioplegia Solution with Handmade St. Thomas Cardioplegia Solution in terms of Quantitative Levels of Cardiac Troponin I and Phosphocreatine kinase MB in Ventricular Septal Defect Repair in Pediatric Cardiac Surgery.
Public title
The Effect of Handmade Del Nido Cardioplegia Solution with Handmade St. Thomas Cardioplegia Solution in terms of Quantitative Levels of Cardiac Troponin I and Phosphocreatine kinase MB.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having less than 12 years of age.
Parental satisfaction from intervention.
Exclusion criteria:
Having a history of heart failure.
Having a history of myocardial infarction.
Age
To 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Female or male patients undergoing surgical repair of large-inferior ventricular diarrhea were easily and conveniently distributed in Chamran Hospital in Isfahan. Then they are randomly assigned random allocation and random numbers in two groups of 30, which will be used in a group of St. Thomas's handmade solution and in another group of Del NIDO solution.
Blinding (investigator's opinion)
Single blinded
Blinding description
The samples are not aware of the therapeutic type and only the presenter is aware of the categorization of patients in each treatment group. Because these two solutions are injected during surgery, so patients are unaware of their drug type.
Placebo
Not 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
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-01-20, 1397/10/30
Ethics committee reference number
IR.MUI.MED.REC.1397.193
Health conditions studied
1
Description of health condition studied
Ventricular Septal Defect Repair
ICD-10 code
I23.2
ICD-10 code description
Ventricular septal defect as current complication following acute myocardial infarction
Primary outcomes
1
Description
Quantitative Levels of Cardiac Troponin I
Timepoint
Before surgery, six hours and 12 hours after surgery.
Method of measurement
Patient blood sample test
2
Description
Quantitative Levels of Phosphocreatine kinase MB
Timepoint
Before surgery, six hours and 12 hours after surgery.
Method of measurement
Patient blood sample test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: 30 patients receiving St. Thomas cardiopulmonary by hand perfringens with a dose of 20 ml per kg and at a temperature of 4 degrees Celsius. This solution is surgically dispensed immediately before injection of the cardioplegia solution sterilized. Then, through a cardioplegia cannula inserted by the surgeon at the root of the aorta, it is injected through the syringe. The injection rate of the cardiopulse solution is 30 to 40 mmHg and during 2 minutes and is controlled by pressure gauge in the injection route. This solution is injected into the patient in a single dose.
Category
Treatment - Surgery
2
Description
Intervention group: Intervention group: 30 patients with cardiogenic cardiopulmonary bypass grafting by perfusion. This solution is a dose of 15 ml per kilogram and a ratio of four crystalloid units at 4 ° C and one unit of complete oxygenated blood. Both solutions are surgically dispensed sterilized immediately after injection of the cardiopulmonary solution. A cardioplegia cannula inserted by the surgeon at the root of the aorta is injected through the syringe. The injection rate of the cardiopulse solution is 30 to 40 mmHg and in the It is in 2 minutes and is controlled by pressure gauge in the injection route. This solution is injected into the patient in a single dose.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital in Isfahan
Full name of responsible person
Hamid Bigdelian
Street address
Shahid Chamran Hospital, Salman Farsi Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3260 0965
Email
mortezasadeghi16@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba FarajZadegan
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
dean@med.mui.ac.ir
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
Hamid Bigdelian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 316680048
Email
mortezasadeghi16@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Bigdelian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mortezasadeghi16@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Bigdelian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mortezasadeghi16@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is unpublished after being unidentifiable and two years after the article is published.
When the data will become available and for how long
Two years after the publication and publication of the results.
To whom data/document is available
Assistants and Professors of the Department of Heart Surgery and Circulation Technology.
Under which criteria data/document could be used
To compare the effects of other handmade solutions on the low levels of troponin I and phospho creatine kinase MB with the present results.
From where data/document is obtainable
Accepting permission from the research vice president of Isfahan University of Medical Sciences.
What processes are involved for a request to access data/document
Accepting permission from the research vice president of Isfahan University of Medical Sciences.