Effect of Reducing the Intervals Between Two Injections of Del Nido Cardioplegia on Clinical Outcomes of Pediatrics with Tetralogy of Fallot Who Undergoing Cardiopulmonary Bypass
Determining the effect of reducing the time interval between two injections of Del Nido cardioplegia on the clinical outcomes of children undergoing complete tetralogy of Fallot repair surgery
Design
A clinical trial with a control group, with parallel groups, single-blind, randomized, phase 3 on 44 patients. Create a Randomization list software is used for randomization.
Settings and conduct
This study will be performed in Shahid Rajaei Cardiovascular Educational, Research and Treatment Center in 1401 in children. The study population will include all patients with congenital tetralogy disorder of Fallot and undergo open heart surgery with cardiopulmonary bypass and weigh less than 10 kg.
Participants/Inclusion and exclusion criteria
1) Parents' consent to participate in the research project 2) Sick infants up to 10 kg candidate for open-heart surgery 3) Aortic clamp duration between 60 to 180 minutes 4) Sternotomy 5) No intubation before surgery 6) Elective surgery
Intervention groups
In the intervention group, the interval between two doses of Del Nido cardioplegia will be reduced to 40 minutes. Patients in the control group will receive Del Nido cardioplegia every 60 minutes.
Main outcome variables
Evaluation of coronary sinus lactate, troponin, creatine phosphokinase
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220424054638N1
Registration date:2022-06-22, 1401/04/01
Registration timing:registered_while_recruiting
Last update:2022-06-22, 1401/04/01
Update count:0
Registration date
2022-06-22, 1401/04/01
Registrant information
Name
Yalda Asheghi
Name of organization / entity
Rajayi cardiovascular center
Country
Iran (Islamic Republic of)
Phone
+98 41 3383 9021
Email address
yaldaasheghi@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Reducing the Intervals Between Two Injections of Del Nido Cardioplegia on Clinical Outcomes of Pediatrics with Tetralogy of Fallot Who Undergoing Cardiopulmonary Bypass
Public title
The effect of reducing the time interval between two injections of Del Nido cardioplegia on clinical outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cardiac Surgery in Children with Tetralogy of Fallot Undergoing Cardiopulmonary bypass Weighing Less than 10 kg
The Time of Cross-clamping Between 60-180 Minute
Obtain Informed Consent from Parents
Sternotomy
Lack of Intubation before Surgery
Elective Surgery
Exclusion criteria:
Severe Hypothermia below 25 ° C
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into 4 permutation blocks using size 4 randomized alternation list intervention (control including 11 blocks of 4, with 4, 3, 2, 1 = Sequence within blocks ).
For example, the first 4 blocks are A-B-B-B. This means that the first patient was selected according to the randomization of the program (A) and the intervention will be performed on this patient. The second patient (B) was selected, as a control group member and so on.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a randomized controlled clinical trial with a single blind (patient not knowing about the intervention) and after obtaining the informed consent of the patient's parents and observing the admission cases, the patient is anesthetized due to surgery and intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Rajaei Cardiovascular University
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection Tehran Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2021-12-04, 1400/09/13
Ethics committee reference number
IR.RHC.REC.1400.080
Health conditions studied
1
Description of health condition studied
Patients with congenital tetralogy of Fallot
ICD-10 code
Q21.3
ICD-10 code description
Tetralogy of Fallot
Primary outcomes
1
Description
Troponin
Timepoint
Before the intervention, enter the intensive care unit and 24 hours later
Method of measurement
Laboratory kits
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" In the intervention group, the interval between two doses of Del Nido cardioplegia will be reduced to 40 minutes. The first dose of cardioplegia in all patients will be 20 ml / kg and the second dose will be half of the first dose. The temperature of cardioplegia will be between 8-12 degrees Celsius and will be injected antigradically after aortic clamping in the aortic root.
Category
Other
2
Description
"Control group:" In the control group, del Nido cardioplegia will be injected as usual ,every 60 minutes. The first dose of cardioplegia in all patients will be 20 ml / kg and the second dose will be half of the first dose. The temperature of cardioplegia will be between 8-12 degrees Celsius and will be injected antigradically after aortic clamping in the aortic root.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Cardiovascular Hospital
Full name of responsible person
Yalda Asheghi
Street address
Shahid Rajaei Cardiovascular Training, Research and Treatment Center، Vali Asr St، Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
yalda.asheghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Yalda Asheghi
Street address
Shahid Rajaei Cardiovascular Training, Research and Treatment Center، Vali Asr St، Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
yalda.asheghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Rajayi cardiovascular center
Full name of responsible person
Yalda Asheghi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesia
Street address
Shahid Rajaei Cardiovascular Training, Research and Treatment Center، Vali Asr St، Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
yalda.asheghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Rajayi cardiovascular center
Full name of responsible person
Yalda Asheghi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesia
Street address
Shahid Rajaei Cardiovascular Training, Research and Treatment Center، Vali Asr St، Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
yalda.asheghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Rajayi cardiovascular center
Full name of responsible person
Yalda Asheghi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesia
Street address
Shahid Rajaei Cardiovascular Training, Research and Treatment Center، Vali Asr St، Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
yalda.asheghi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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
No - There is not 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