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IRCT20090111001545N5 IRCT 2020-03-03 Rasht University of Medical Sciences Comparison of the frequency of acute hemolysis induced nephropathy in patients with glucose 6 phosphate dehydrogenase deficiency treated with 3 different therapeutic fluid treatments Comparison of the frequency of acute hemolysis induced nephropathy in patients with glucose 6 phosphate dehydrogenase deficiency treated with 3 different therapeutic fluid treatments 2019-04-09 anticipated 132 Complete https://irct.ir/trial/39571 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization, randomization unit: individual, randomization tool: random number table Patients who met the inclusion criteria were selected by a random number table from left to right reading method. The numbers were between 00 and44 in group1 and patients with numbers between 44 and 88 in group 2 and patients with numbers from 88 to132 were divided into group 3. N/A Glucose 6 Phosphate Dehydrogenase Deficiency. Intervention group 1: Receiving 1.5 folds of maintenance normal saline serum which will be continued until discharge, Intervention group 2: Receiving 1.5 folds of maintenance half saline which will be continued until discharge + 7 cc bicarbonate/liter, Intervention group 3: Receiving 1.5 folds of maintenance normal saline which will be continued until discharge + 5 mg/ kg/ day Acetazolamide for 48 hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is Regarding the ethical issues and confidentiality
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Rasht Iran (Islamic Republic of) 4144654679 +98 13 3336 9002 badeli45@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) age : 3 months - 18 years old hemoglobinuria ≥ 2+ intra venous fluid therapy for at least 24 hours acute hemolysis induced Favism or glucose 6 phosphate dehydrogenase deficiency hospitalization for 24 to 72 hours 3 months 18 years Both Presence of Dysatremia Central Diabetes insipidus or renal Diabetes insipidus Barrett's Syndrome Nephrotic Syndrome Chronic Kidney Disease Congestive heart failure Liver cirrhosis Metabolic diseases Diabetic ketoacidosis Congenital adrenal hypoplasia shock Glaucoma Addison's disease Unwiling to participate D55.0 Anemia due to glucose-6-phosphate dehydrogenase [G6PD] deficiency Treatment - Drugs Intervention group 1: Receiving 1.5 folds of maintenance normal saline serum which will be continued until discharge, Intervention group 2: Receiving 1.5 folds of maintenance half saline which will be continued until discharge + 7 cc bicarbonate/liter, Intervention group 3: Receiving 1.5 folds of maintenance normal saline which will be continued until discharge + 5 mg/ kg/ day Acetazolamide for 48 hours The Frequency of Nephropathy due to Acute Hemolysis. Timepoint: Assessing the frequency of Nephropathy before intervention and 6, 12, 24, 48, and 72 hours after intervention. Method of measurement: Laboratory examination. Vice Chancellor of Reserach- Guilan University of Medical Sciences Approved 2019-04-13 Ethics committee of Guilan University of Medical Sciences Shahid Siadati Rasht Guilan Iran (Islamic Republic of)