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IRCT20180522039787N1 IRCT 2018-08-27 Shahid Rajae Cardiovascular and Research Center effect of albumin in pediatric surgery Compare the effects of 5% albumin dose versus 2% in prime solution on fluid balance in heart surgery on congenital heart disease in newborn and infant 2018-03-06 anticipated 60 Complete https://irct.ir/trial/31595 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a random block was used. Random units are individual. The randomization tool in this study is a random numbered table. The size of each block is 5, Blinding description: In this study, after cardiac surgery, all specimens are under echocardiography to check for ascites and efusion, which the pediatric cardiologist, who is responsible for this task, is blind to the study. The respectable perfusionists and the relevant heart surgeon are also blind to the patients. Nurses also do not know how to share patients. But the main investigator who is responsible for recording data is not blind to the study. After determining the placement of the sample in the control group or the intervention, we prepare a sample of the primer solution. Regarding the used oxygenator, the serum level used for primers is different. For each 100 cc of serum, 5 g of albumin in the intervention group and 2 g in the control group are used to reach the desired crop. It should be noted that perfusionists who prepare prime solution for the patient are blind to the study. 3 congenital heart desease. Intervention 1: The intervention group in this study is a patient with albumin concentration of 5% in prime solutions.First, the appropriate oxygenator is selected with the patient and is primed with a ringer serum. Corresponding to the amount of ringer serum used to reach 5% concentration of albumin in prime solution, 20% vial of albumin available in the hospital is used. The albumin has been used in 50cc vials at a concentration of 20% in the hospital. For example, if 200 cc of the ringer is used for the oxygenator prime, 10 g of albumin is added to the prime solution to achieve a 5% concentration of albumin in the patient's prime solution. Only in prime solution and once using albumin, then the process of preparing the patient and the equipment continues to proceed. Intervention 2: Control group: The control group in this study is a patient with albumin concentration of 2% in prime solutions.First, the appropriate oxygenator is selected with the patient and is primed with a ringer serum. Corresponding to the amount of ringer serum used to reach 2% concentration of albumin in prime solution, 20% vial of albumin available in the hospital is used. The albumin has been used in 50cc vials at a concentration of 10% in the hospital. For example, if 200 cc of the ringer is used for the oxygenator prime, 4 g of albumin is added to the prime solution to achieve a 5% concentration of albumin in the patient's prime solution. Only in prime solution and once using albumin, then the process of preparing the patient and the equipment continues to proceed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Amirhosein Salehzade
Shahid Rajae Heart Center.Valieasr Ave
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 a.salehzade@rhc.ac.ir Shahid Rajae Cardiovascular and Research Center scientific Amirhosein Salehzade
Shahid Rajae Heart Center.Valieasr Ave
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 a.salehzade@rhc.ac.ir Shahid Rajae Heart Center Iran (Islamic Republic of) Parental satisfaction regarding participation in research project Age 5 days to 2 years Weight less than or equal to 10 kg Patients candidated for open heart surgery Congenital anomaly of the heart Duration of cardiopulmonary bypass[ for at least one hour and maximum three hours 5 days 2 years Both Deep hypothermia low cardiac output edema or ascites before surgery Infection and inflammation known a week before surgery emergency surgery Not consenting parents to enter the trial Q25.0 Patent ductus arteriosus Treatment - Devices Treatment - Devices The intervention group in this study is a patient with albumin concentration of 5% in prime solutions.First, the appropriate oxygenator is selected with the patient and is primed with a ringer serum. Corresponding to the amount of ringer serum used to reach 5% concentration of albumin in prime solution, 20% vial of albumin available in the hospital is used. The albumin has been used in 50cc vials at a concentration of 20% in the hospital. For example, if 200 cc of the ringer is used for the oxygenator prime, 10 g of albumin is added to the prime solution to achieve a 5% concentration of albumin in the patient's prime solution. Only in prime solution and once using albumin, then the process of preparing the patient and the equipment continues to proceed. Control group: The control group in this study is a patient with albumin concentration of 2% in prime solutions.First, the appropriate oxygenator is selected with the patient and is primed with a ringer serum. Corresponding to the amount of ringer serum used to reach 2% concentration of albumin in prime solution, 20% vial of albumin available in the hospital is used. The albumin has been used in 50cc vials at a concentration of 10% in the hospital. For example, if 200 cc of the ringer is used for the oxygenator prime, 4 g of albumin is added to the prime solution to achieve a 5% concentration of albumin in the patient's prime solution. Only in prime solution and once using albumin, then the process of preparing the patient and the equipment continues to proceed. Albumin. Timepoint: At the beginning of the study (before the study started) - Immediately in the intensive care unit - 24 hours later in the intensive care unit. Method of measurement: Albumin Measuring Laboratory Kit. On fluid balance. Timepoint: At the beginning of the study (before the study started) - Immediately in the intensive care unit - 24 hours later in the intensive care unit. Method of measurement: Laboratory kit measuring body electrolytes. Shahid Rajae Cardiovascular and Research Center Approved 2018-02-17 Ethics Committee at Shahid Rajaee Cardiology Hospital of Tehran valiasr Ave. niayesh blvd. shahid rajae cardiovascular and research center tehran Tehran Iran (Islamic Republic of)