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IRCT20220424054638N1 IRCT 2022-06-22 Iran University of Medical Sciences The effect of reducing the time interval between two injections of Del Nido cardioplegia on clinical outcomes 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 2022-06-22 anticipated 44 Complete https://irct.ir/trial/63268 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Patients with congenital tetralogy of Fallot. Intervention 1: "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. Intervention 2: "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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Yalda Asheghi
Shahid Rajaei Cardiovascular Training, Research and Treatment Center، Vali Asr St، Tehran
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 yalda.asheghi@gmail.com Shahid Rajayi cardiovascular center scientific Yalda Asheghi
Shahid Rajaei Cardiovascular Training, Research and Treatment Center، Vali Asr St، Tehran
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 yalda.asheghi@gmail.com Shahid Rajayi cardiovascular center Iran (Islamic Republic of) 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 no limit no limit Both Severe Hypothermia below 25 ° C Q21.3 Tetralogy of Fallot Other N/A "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. "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. Troponin. Timepoint: Before the intervention, enter the intensive care unit and 24 hours later. Method of measurement: Laboratory kits. Iran University of Medical Sciences Approved 2021-12-04 Ethics Committee of Shahid Rajaei Cardiovascular University Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection Tehran Iran Tehran Tehran Iran (Islamic Republic of)