]>
IRCT20160713028901N5 IRCT 2024-01-10 Esfahan University of Medical Sciences Colistin infusion Effect of increasing the duration of Colistin infusion on nephrotoxicity 2024-01-20 anticipated 30 Complete https://irct.ir/trial/74855 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method using blocks of four. Information such as the number of treatment groups (2 main intervention groups, for example, A and control for example B), the size of the blocks (a multiple of the number of groups that will be chosen in this study to reduce the complexity of the work, size 4) and the total number of patients (sample size 40 people) to the internet software machines specific for this calculation (for example available at https://www.sealedenvelope.com/simple-randomiser/v1/lists) and according to the codes that are included in the final analysis (including the number of particular groups 4 of which will be 17 groups) is obtained; each of the patients who enter the study is assigned a code that will determine the type of group. Blocking is usually done to balance the number of samples assigned to each. The studied groups will be used. In this method, equal blocking will be used. In this way, the samples will be randomized as much as possible in the same way in two groups. 4 Kidney failure. Intervention 1: Intervention group: For people in the intervention group, colistin will be prescribed as a long-term infusion (6 hours). People who, for any reason, received the drug colistin with a standard dose of 150 mg (equivalent to 4.5 million units of sodium colistimethate) or a dose according to their renal function every 12 hours and who meet the other criteria for entering the study, were randomly They will be placed in two intervention and control groups. Demographic and clinical characteristics of patients, including age, sex, body weight, current illness, past medical history, history of underlying kidney disease, other antibiotic treatments, duration of colistin use, concurrently prescribed drugs, inpatient department, and diagnosis (indication for drug use) and drug-related points including date, time, dose and duration of injection will be recorded. For the people in the intervention group, colistin will be prescribed as a long-term infusion (6 hours). The drug is infused in 500 ml of normal saline without adding other medications through a separate line. The drug dose may be adjusted according to the patient's renal function to consider clinical performance patterns. The physician will evaluate the patient's clinical symptoms during the treatment period. Intervention 2: Control group: The control group will receive colistin with the usual 1-hour administration method. People who, for any reason, received the drug colistin with a standard dose of 150 mg (equivalent to 4.5 million units of sodium colistimethate) or a dose according to their renal function every 12 hours and who meet the other criteria for entering the study, were randomly They will be placed in two intervention and control groups. Demographic and clinical characteristics of patients, including age, sex, body weight, current illness, past medical history, history of underlying kidney disease, other antibiotic treatments, duration of colistin use, concurrently prescribed drugs, inpatient department, and diagnosis (indication for drug use) and drug-related points including date, time, dose and duration of injection will be recorded. The control group will receive colistin with the usual 1-hour administration method. The drug is infused in 500 ml of normal saline without adding other medications through a separate line. The drug dose may be adjusted according to the patient's renal function to consider clinical performance patterns. The physician will evaluate the patient's clinical symptoms during the treatment period. No - There is not a plan to make this available Justification or reason for not sharing IPD is confidentiality
public Shirinsadat Badri
Hezar jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8064 badri@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Shirinsadat Badri
Hezar jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8064 badri@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 50 years Receiving colistin at a dose of 4.5 million units every 12 hours (or an equivalent dose according to the patient's kidney function) Creatinine clearance above 50 ml/min at the beginning of the study No history of acute kidney injury (based on history and medical history) Failure to receive other nephrotoxic drugs such as aminoglycosides, amphotericin B, cyclosporine, tacrolimus, furosemide and NSAIDs Not receiving other antioxidant supplements such as vitamins C and E 18 years 50 years Both Recent use of colistin in the last 7 days Using colistin for less than 3 days Dialysis before starting treatment N17 Acute kidney failure Treatment - Drugs Treatment - Drugs Intervention group: For people in the intervention group, colistin will be prescribed as a long-term infusion (6 hours). People who, for any reason, received the drug colistin with a standard dose of 150 mg (equivalent to 4.5 million units of sodium colistimethate) or a dose according to their renal function every 12 hours and who meet the other criteria for entering the study, were randomly They will be placed in two intervention and control groups. Demographic and clinical characteristics of patients, including age, sex, body weight, current illness, past medical history, history of underlying kidney disease, other antibiotic treatments, duration of colistin use, concurrently prescribed drugs, inpatient department, and diagnosis (indication for drug use) and drug-related points including date, time, dose and duration of injection will be recorded. For the people in the intervention group, colistin will be prescribed as a long-term infusion (6 hours). The drug is infused in 500 ml of normal saline without adding other medications through a separate line. The drug dose may be adjusted according to the patient's renal function to consider clinical performance patterns. The physician will evaluate the patient's clinical symptoms during the treatment period. Control group: The control group will receive colistin with the usual 1-hour administration method. People who, for any reason, received the drug colistin with a standard dose of 150 mg (equivalent to 4.5 million units of sodium colistimethate) or a dose according to their renal function every 12 hours and who meet the other criteria for entering the study, were randomly They will be placed in two intervention and control groups. Demographic and clinical characteristics of patients, including age, sex, body weight, current illness, past medical history, history of underlying kidney disease, other antibiotic treatments, duration of colistin use, concurrently prescribed drugs, inpatient department, and diagnosis (indication for drug use) and drug-related points including date, time, dose and duration of injection will be recorded. The control group will receive colistin with the usual 1-hour administration method. The drug is infused in 500 ml of normal saline without adding other medications through a separate line. The drug dose may be adjusted according to the patient's renal function to consider clinical performance patterns. The physician will evaluate the patient's clinical symptoms during the treatment period. Serum creatinine level (SCr). Timepoint: before starting the treatment, during the treatment for one day in between and also 12 hours after the last dose of colistin on the tenth day of treatment with this antibiotic (before receiving any other dose of colistin). Method of measurement: Hospital laboratory. Blood urea nitrogen (BUN). Timepoint: before starting the treatment, during the treatment for one day in between and also 12 hours after the last dose of colistin on the tenth day of treatment with this antibiotic (before receiving any other dose of colistin). Method of measurement: Hospital laboratory. Creatinine clearance (CrCl). Timepoint: before starting the treatment, during the treatment for one day in between and also 12 hours after the last dose of colistin on the tenth day of treatment with this antibiotic (before receiving any other dose of colistin). Method of measurement: calculating by equation. Esfahan University of Medical Sciences Approved 2023-06-20 Vice Chancellor of Research, Isfahan University of Medical Sciences (Research Ethics Committee) Hezar jerib Isfahan Isfehan Iran (Islamic Republic of)