Clinical Trial Protocol Iranian Registry of Clinical Trials

24 Sep 2021

Comparison of the frequency of acute hemolysis induced nephropathy in patients with glucose 6 phosphate dehydrogenase deficiency treated with 3 different therapeutic fluid treatments

Protocol summary General information

Study aim Reason for update The aim of this study is to determine the frequency of Acronym nephropathy-induced by acute hemolysis in patients with IRCT registration information glucose-6-phosphate dehydrogenase deficiency treated IRCT registration number: IRCT20090111001545N5 with 3 different fluid therapy methods. Registration date: 2020-03-03, 1398/12/13 Design Registration timing: registered_while_recruiting A clinical trial with a control group, with parallel-group, randomized, 132 patients, phase 3 Last update: 2020-03-03, 1398/12/13 Settings and conduct Update count: 0 In this randomized double-blind clinical trial study, Registration date infants and children aged 3 months to 18 years with 2020-03-03, 1398/12/13 acute hemolysis due to G6PD deficiency admitted to Shahrivar Hospital in Rasht in 1398 requiring at least 24 Registrant information hours fluid therapy and hospitalization for follow-up will Name be studying for 24 to 72 hours. Hamidreza Badeli Participants/Inclusion and exclusion criteria Name of organization / entity Inclusion criteria: age 3 months to 18 years, urinary Guilan University of Medical Sciences hemoglobin more or equal to + 2, need to receive Country Iran (Islamic Republic of) intravenous fluids for at least 24 hours, acute hemolysis Phone caused by favism or G6PD deficiency, hospitalization for +98 13 1322 9523 24 to 72 hours Exclusion criteria: Patients will be Email address excluded if any of the following adverse events occur: [email protected] sodium levels below 130 and above 150, neurological symptoms of hyponatremia, symptoms of fluid retention Recruitment status and general puffiness,Oligo Anuric renal failure Recruitment complete Intervention groups Funding source Intervention group 1: Receiving 1.5 folds of maintenance normal saline serum which will be continued until Expected recruitment start date discharge, Intervention group 2: Receiving 1.5 folds of 2019-04-09, 1398/01/20 maintenance half saline which will be continued until Expected recruitment end date discharge + 7 cc bicarbonate/liter, Intervention group 3: 2020-06-20, 1399/03/31 Receiving 1.5 folds of maintenance normal saline which Actual recruitment start date will be continued until discharge + 5 mg/ kg/ day empty Acetazolamide for 48 hours Actual recruitment end date Main outcome variables empty The Frequency of Nephropathy due to Acute Hemolysis Trial completion date

1 empty Ethics committees Scientific title Comparison of the frequency of acute hemolysis induced 1 nephropathy in patients with glucose 6 phosphate Ethics committee dehydrogenase deficiency treated with 3 different Name of ethics committee therapeutic fluid treatments Ethics committee of Guilan University of Medical Public title Sciences Comparison of the frequency of acute hemolysis induced Street address nephropathy in patients with glucose 6 phosphate Shahid Siadati dehydrogenase deficiency treated with 3 different City therapeutic fluid treatments Rasht Purpose Province Treatment Guilan Postal code Inclusion/Exclusion criteria 4144654679 Inclusion criteria: Approval date age : 3 months - 18 years old hemoglobinuria ≥ 2+ intra 2019-04-13, 1398/01/24 venous fluid therapy for at least 24 hours acute Ethics committee reference number hemolysis induced Favism or glucose 6 phosphate IR.GUMS.REC.1398.026 dehydrogenase deficiency hospitalization for 24 to 72 hours Exclusion criteria: Health conditions studied Presence of Dysatremia Central Diabetes insipidus or renal Diabetes insipidus Barrett's Syndrome Nephrotic 1 Syndrome Chronic Kidney Disease Congestive heart failure Liver cirrhosis Metabolic diseases Diabetic Description of health condition studied ketoacidosis Congenital adrenal hypoplasia shock Glucose 6 Phosphate Dehydrogenase Deficiency Glaucoma Addison's disease Unwiling to participate ICD-10 code Age D55.0 From 3 months old to 18 years old ICD-10 code description Gender Anemia due to glucose-6-phosphate dehydrogenase Both [G6PD] deficiency

Phase Primary outcomes N/A Groups that have been masked No information 1 Sample size Description Target sample size: 132 The Frequency of Nephropathy due to Acute Hemolysis Randomization (investigator's opinion) Timepoint Randomized Assessing the frequency of Nephropathy before Randomization description intervention and 6, 12, 24, 48, and 72 hours after Randomization method: Simple randomization, intervention randomization unit: individual, randomization tool: Method of measurement random number table Patients who met the inclusion Laboratory examination 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 Secondary outcomes 44 and 88 in group 2 and patients with numbers from 88 empty to132 were divided into group 3. Blinding (investigator's opinion) Intervention groups Not blinded Blinding description Placebo 1 Not used Description Assignment Intervention group 1: Receiving 1.5 folds of maintenance Parallel normal saline serum which will be continued until Other design features discharge, Intervention group 2: Receiving 1.5 folds of maintenance half saline which will be continued until Secondary Ids discharge + 7 cc bicarbonate/liter, Intervention group 3: Receiving 1.5 folds of maintenance normal saline which empty will be continued until discharge + 5 mg/ kg/ day

2 Acetazolamide for 48 hours Domestic or foreign origin Category Domestic Treatment - Drugs Category of foreign source of funding empty Recruitment centers Country of origin Type of organization providing the funding Academic 1 Recruitment center Person responsible for general inquiries Name of recruitment center 17-Shahrivar Children Hospital Contact Full name of responsible person Name of organization / entity Hamidreza Badeli Rasht University of Medical Sciences Street address Full name of responsible person Siadati St Hamidreza Badeli City Position Rasht Associate professor Province Latest degree Guilan Subspecialist Postal code Other areas of specialty/work 41144654839 Pediatrics Phone Street address +98 13 3336 9002 Namjou Ave,Shadid Siadati St,Rasht Fax City +98 13 3336 9061 Rasht Email Province [email protected] Guilan Web page address Postal code 4144654839 Phone Sponsors / Funding sources +98 13 3336 9002 Fax 1 +98 13 3336 9070 Email Sponsor [email protected] Name of organization / entity Rasht University of Medical Sciences Full name of responsible person Person responsible for scientific Shadman Nemati inquiries Street address Siadati Street Contact City Name of organization / entity Rasht Rasht University of Medical Sciences Province Full name of responsible person Guilan Hamidreza Badeli Postal code Position 4144654679 Associate professor Phone Latest degree +98 13 3333 5820 Medical doctor Email Other areas of specialty/work [email protected] Pediatrics Grant name Street address Grant code / Reference number Siadati Street Is the source of funding the same sponsor City organization/entity? Rasht No Province Title of funding source Guilan Vice Chancellor of Reserach- Guilan University of Medical Postal code Sciences 4144654679 Proportion provided by this source Phone 100 +98 13 3336 9002 Public or private sector Email Public [email protected]

3 Person responsible for updating data Fax Email Contact [email protected] Name of organization / entity Web page address Rasht University of Medical Sciences Full name of responsible person Hamidreza Badeli Sharing plan Position Deidentified Individual Participant Data Set (IPD) Nephrologist and Associate Professor of Guilan No - There is not a plan to make this available University of Medical Sciences Justification/reason for indecision/not sharing IPD Latest degree Regarding the ethical issues and confidentiality Subspecialist Study Protocol Other areas of specialty/work Pediatrics No - There is not a plan to make this available Street address Statistical Analysis Plan Shahid Siadati Street No - There is not a plan to make this available City Informed Consent Form Rasht No - There is not a plan to make this available Province Clinical Study Report Guilan No - There is not a plan to make this available Postal code Analytic Code 4144654679 No - There is not a plan to make this available Phone Data Dictionary +98 13 3336 9002 No - There is not a plan to make this available

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