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IRCT20120415009475N11 IRCT 2022-02-22 Shahid Beheshti University of Medical Sciences Albumin and Furosemide in Nephrotic Syndrome Comparison of Sequential versus Concurrent Albumin and Furosemide in Pediatric Nephrotic Syndrome Patients 2022-02-20 anticipated 128 Complete https://irct.ir/trial/57085 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization has been performed using the block randomization table. In this method, the total study population is divided into small blocks, and randomization is performed inside the block. This method results in more homogeneity between the intervention and control groups. A list of four patient blocks is generated by sealedenvelope.com site is provided to the designated allocation person, in each recruitment the researcher is informed of allocation by telephone, Blinding description: The medication and placebo will be in look-alike coded packages, and the codes based on the block randomization table will be provided to the researcher by a designated person via phone. At the end of the study, after organizing the data by the same person, the statistical expert will perform the analysis. Then, the code packet will be opened, and the final results will be reported. 2-3 Nephrotic syndrome. Intervention 1: Intervention group: Receives a mixture of albumin and furosemide simultaneously. In this group, 10 milligrams of Furosemide is added to a 50 milliliters vial of Albumin 20 percent and for each kilogram of patient weight 5 milliliters would be infused over 1 hour. Intervention 2: Intervention group: Receive Furosemide Upon completion of albumin. In this group, 5 milliliters of Albumin 20 percent for each kilogram of patient weight is infused over one hour, and after completion of infusion 1 milligram of Furosemide injection would be injected into the patient. Yes - There is a plan to make this available What will be shared: The main outcome will be available. When: Six months after publishing. To whom: The data will be available per request for people working in academic institutions Conditions: The data will available for using in systematic review and meta-analysis. Where to obtain: The data will be available by contacting email; mirrahimi@sbmu.ac.ir. How to obtain: The data will available for using in systematic review and meta-analysis. Comments:
public Fatemeh Tadayoni
No. 3.1, Shahid Honjani Alley, Shahid Salehi Ave, Abrisham Ave, Shahid Rajaei Blvd, Tehran Town
Tehran Iran (Islamic Republic of) 1838738697 +98 21 5507 8498 ph.fatemeh.tadayoni@gmail.com Islamic Azad University scientific Dr. Bahador Mirrahimi
Mofid children's Hospital, Miradmad Junction, Shariaty Ave.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7020 mirrahimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) ََAge between 2 to 15 years Diagnosis of Nephrotic Syndrome 2 years 15 years Both Allergy to Albumin Allergy to Furosemide Urine output less than 0.5 ml/kg/hr N04 Nephrotic syndrome Treatment - Drugs Treatment - Drugs Intervention group: Receives a mixture of albumin and furosemide simultaneously. In this group, 10 milligrams of Furosemide is added to a 50 milliliters vial of Albumin 20 percent and for each kilogram of patient weight 5 milliliters would be infused over 1 hour. Intervention group: Receive Furosemide Upon completion of albumin. In this group, 5 milliliters of Albumin 20 percent for each kilogram of patient weight is infused over one hour, and after completion of infusion 1 milligram of Furosemide injection would be injected into the patient. Patient weight. Timepoint: 24 hours after intervention. Method of measurement: Weighing the patient. Urine sodium level. Timepoint: 24 hours after intervention. Method of measurement: urine analysis. Shahid Beheshti University of Medical Sciences Approved 2021-05-29 institutional ethics committee for Pharmacy, Nursing and Midwifery Schools 2nd floor, School of Nursing and Midwifery, Valiasr and Niayesh junction Tehran Tehran Iran (Islamic Republic of)