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IRCT20200328046886N5 IRCT 2023-10-21 Mazandaran University of Medical Sciences Evaluation of the effect of NAC in colistin-induced nephrotoxicity Evaluation of Effect of N-acetylcysteine On Rate and Severity of Colistin Nephrotoxicity: A Randomized Double-blind Placebo-controlled Trial 2023-10-23 anticipated 48 Complete https://irct.ir/trial/72834 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: To perform randomization, a list of all eligible patients will be prepared first. Using the Excel program, a unique 4-digit code (unique ID) will be considered for each patient. Patients will be placed in two N-acetylcysteine (NAC) and placebo groups based on blocks of 4. The grouping of patients and the type of intervention received are at the disposal of the first project manager, and the patient, the clinical pharmacy assistant who is in charge of clinical evaluations, and the statistical analyst will not know about the grouping of patients. Medicine and placebo will be provided from the same pharmaceutical company. Then, for the control group, 24 cases will be randomly selected using Excel software (Random Sampling) and the remaining cases will be classified as the intervention group, Blinding description: This study will be double blinded. In this way, the patient, doctor and clinical evaluator will not know about the drug used (N-acetylcysteine or placebo). Medicines and placebos are prepared from a pharmaceutical company and are used for each patient in a similar pharmaceutical form marked with a four-digit code. 2-3 nephrotoxicity. Intervention 1: In the intervention group, patients will be given N-Acetylcysteine (NAC) at a dose of 2 gr intravenously once a day for 5 days along with colistin with a loading dose of 300 mg colistin base activity(CBA) (~9 million IU) and a maintenance dose of 275-360 mg CBA (~9-10.9 million IU) infused in two divided doses every 12 hours for half an hour. Patients with reduced kidney function will receive the dose based on GFR as below: CrCl ≥90 mL/minute: 360 mg CBA/dayCrCl 80 to <90 mL/minute: 340 mg CBA/dayCrCl 70 to <80 mL/minute: 300 mg CBA/dayCrCl 60 to <70 mL/minute: 275 mg CBA/day. Intervention 2: In the control group of patients, the placebo injection form of N-acetylcysteine with a dose of 2 grams intravenously once a day for 5 days along with colistin with a loading dose of 300 mg colistin base activity(CBA) (~9 million IU) and a maintenance dose of 275-360 mg CBA (~9-10.9 million IU) infused in two divided doses every 12 hours for half an hour. Patients with reduced kidney function will receive the dose based on GFR as below: CrCl ≥90 mL/minute: 360 mg CBA/dayCrCl 80 to <90 mL/minute: 340 mg CBA/dayCrCl 70 to <80 mL/minute: 300 mg CBA/dayCrCl 60 to <70 mL/minute: 275 mg CBA/day. No - There is not a plan to make this available Justification or reason for not sharing IPD is There are no plans to publish the study protocol separately as it is available on IRCT
public Hamideh abbaspour kasgari
Km 18 Khazarabad Boulevard, Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3304 4000 Dr.abbaspour1@yahoo.com Mazandaran University of Medical Sciences scientific Hamideh abbaspour kasgari
Km 18 Khazarabad Boulevard, Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3304 4000 Dr.abbaspour1@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old Use of colistin for five days or longer as IV antimicrobial therapy in patients with nosocomial infections Obtaining a written informed consent form from all patients or their guardians 18 years no limit Both Receive NAC less than 24 hours before the first dose of colistin Patients undergoing hemodialysis or peritoneal dialysis Receiving contrast material for radiological imaging Pregnant and lactating women Known allergy to colistin or N-acetylcysteine (NAC) Patient with recent history of cardiopulmonary resuscitation Patients with systolic blood pressure <90 mmHg GFR<60 ml/min N14.1 Nephropathy induced by other drugs, medicaments and biological substances Prevention Prevention In the intervention group, patients will be given N-Acetylcysteine (NAC) at a dose of 2 gr intravenously once a day for 5 days along with colistin with a loading dose of 300 mg colistin base activity(CBA) (~9 million IU) and a maintenance dose of 275-360 mg CBA (~9-10.9 million IU) infused in two divided doses every 12 hours for half an hour. Patients with reduced kidney function will receive the dose based on GFR as below: CrCl ≥90 mL/minute: 360 mg CBA/dayCrCl 80 to <90 mL/minute: 340 mg CBA/dayCrCl 70 to <80 mL/minute: 300 mg CBA/dayCrCl 60 to <70 mL/minute: 275 mg CBA/day In the control group of patients, the placebo injection form of N-acetylcysteine with a dose of 2 grams intravenously once a day for 5 days along with colistin with a loading dose of 300 mg colistin base activity(CBA) (~9 million IU) and a maintenance dose of 275-360 mg CBA (~9-10.9 million IU) infused in two divided doses every 12 hours for half an hour. Patients with reduced kidney function will receive the dose based on GFR as below: CrCl ≥90 mL/minute: 360 mg CBA/dayCrCl 80 to <90 mL/minute: 340 mg CBA/dayCrCl 70 to <80 mL/minute: 300 mg CBA/dayCrCl 60 to <70 mL/minute: 275 mg CBA/day Urinary N-acetyl-beta-D glucosaminidase (NAG) level. Timepoint: First and fifth day of study. Method of measurement: Through the N-acetyl-beta-D glucosaminidase (NAG) urinary measurement kit. Severity of kidney damage. Timepoint: Daily during the intervention period. Method of measurement: RIFLE classification system. Mazandaran University of Medical Sciences Approved 2023-08-22 Ethics committee of Mazandaran University of Medical Sciencel Khazar abad Blvd, Mazandaran University of Medical of Science Sari Mazandaran Iran (Islamic Republic of)