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IRCT20211219053454N1 IRCT 2022-01-04 Shiraz University of Medical Sciences The effect of subzero balanced –modified ultrafiltration technique on chemical and clinical outcomes in cardiopulmonary bypass of pediatrics undergoing cardiac surgery The effect of subzero balanced –modified ultrafiltration technique on chemical and clinical outcomes in cardiopulmonary bypass of pediatrics undergoing cardiac surgery 2022-02-20 anticipated 80 Complete https://irct.ir/trial/60783 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: To randomly assign samples to each group, a random list obtained from a random number table by permutation block method is used. After receiving the patient in the operating room, his / her characteristics and tests are checked. If he / she meets the conditions for admission to the study, he / she will be assigned to one of the intervention or control groups according to the table of random numbers received from randomization.com, Blinding description: Due to the nature of the study, children undergo surgery are not and will not be aware of the techniques performed during operation. Also, ICU nurses who record most of the information assessed after surgery are not aware of the process and techniques performed in the operating room. N/A Condition 1: Ventricular septal defect. Condition 2: Congenital heart disease. Condition 3: Tetralogy of Fallot. Intervention 1: Intervention group: Children undergoing heart surgery who receive a sub-zero ultrafiltration technique continuously during the bypass, and after the cardiac bypass is completed, the modified ultrafiltration technique will be performed on them for about 10 minutes. Intervention 2: Control group: Children undergoing heart surgery who undergo the conventional ultrafiltration technique when needed and at the discretion of the perfusionist. Yes - There is a plan to make this available What will be shared: Demographic informations When: Start of access period from 1402 To whom: People working and researching in the field of cardiovascular surgery Conditions: All analyzes are allowed Where to obtain: Mr. Mehrtash Shadmehr +989366875622 Mehrtash.shad@yahoo.com How to obtain: Send email and coordinate Comments:
public Khalil Zarrabi
Zand st
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3235 1088 Zarrabisx@gmail.com Shiraz University of Medical Sciences scientific Khalil Zarrabi
Zand st
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3235 1090 Zarrabisx@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) weight between 3 to 30 Kg No renal dysfanction being born term normal blood potassium No transfusions of blood and its products prior to operation age between 0 to 18 1 month 18 years Both weight under 3 and above 3 kg renal dysfunction being born preterm abnormal potassium transfusion of blood and its products age above 18 administered diuretic prior to operation Q21.0 Q24.9 Q21.3 Ventricular septal defect Congenital malformation of heart, unspecified Tetralogy of Fallot Prevention Prevention Intervention group: Children undergoing heart surgery who receive a sub-zero ultrafiltration technique continuously during the bypass, and after the cardiac bypass is completed, the modified ultrafiltration technique will be performed on them for about 10 minutes. Control group: Children undergoing heart surgery who undergo the conventional ultrafiltration technique when needed and at the discretion of the perfusionist Changes in blood potassium during bypass. Timepoint: Measuring the amount of potassium before the bypass and at half-hour intervals during bypass until its end. Method of measurement: Potassium testing is performed with an ABG measuring device in the cardiac operating room. Measuring the amount of blood / products after operation. Timepoint: Daily. Method of measurement: Blood and products are in graduated bags that the amount injected is recorded by the ICU nurse. Measurement of urinary output after surgery. Timepoint: Daily. Method of measurement: Urine is emptied into graduated containers, which are recorded by the ICU nurse on an hourly basis. We calculate the average daily urine output per person. Evaluation the incidence of cardiac dysrhythmia. Timepoint: Constantly. Method of measurement: By ECG monitoring. In case of occurrence, it will be recorded. ICU length of stay. Timepoint: Daily. Method of measurement: The patient entering and leaving the ICU is recorded. Evaluating the GFR during ICU stay. Timepoint: Daily. Method of measurement: GFR determination is calculated by the formula (Schwartz) which has a specific coefficient according to age, height, sex and creatinine. Measurement of blood transfusion during surgery. Timepoint: Hourly during surgery. Method of measurement: The blood is in graduated bags where the amount transfused is recorded. Shiraz University of Medical Sciences Approved 2021-11-16 Ethics committee of Shiraz University of Medical Sciences Zand st. Namazi sq. Shiraz Shiraz Fars Iran (Islamic Republic of)