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IRCT20230312057694N1 IRCT 2023-05-22 Ahvaz University of Medical Sciences The effect of furosemide in the prevention of contrast-induced nephropathy in STEMI patients undergoing Percutaneous Coronary Intervention (PCI) The effect of furosemide in the prevention of contrast-induced nephropathy in STEMI (ST) Elevation Myocardial Infarction patients undergoing Percutaneous Coronary Intervention (PCI) referred to Golestan Hospital between 2023-2024 2023-03-20 anticipated 234 Complete https://irct.ir/trial/69216 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method and explanations of each method: Based on the method of random permutations, people are divided into two groups completely randomly. Randomization Unit: Individual Randomization tool: Random Allocation Software for randomization, sealed envelope random sequence was built: allocating even numbers to group A and odd numbers to group B allocation concealment: Sealed envelopes that are assigned to each participant upon entering, based on which they will be placed in one of the two groups, Blinding description: Patients are divided into two groups receiving furosemide and receiving normal saline (placebo) at the rate of 0.5 mg/kg with a ratio of 1:1. This study is conducted in a double-blind manner, so that the patient, the researcher and the outcome assessors will not have any information about which group the people are in and which medicine they will receive. In this way, the drug and placebo will be completely similar in terms of shape, color, smell, etc. The drugs are in sealed packages that are blinded to the researcher, the patient, and the outcome assessors, and it is not clear which patient receives which drug. 3 Condition 1: Myocardial infarction. Condition 2: Contrast-induced nephropathy. Intervention 1: Intervention group: Recipients of 0.5 mg/kg formeside within one hour after Percutaneous Coronary Intervention (PCI) as a single dose and 1 mg/kg/h of normal saline serum within 24 hours after Percutaneous Coronary Intervention (PCI). Intervention 2: Control group: recipient of normal saline at the rate of 1 mg/kg/h during 24 hours after Percutaneous Coronary Intervention (PCI). Yes - There is a plan to make this available What will be shared: Only the results related to the outcome and output of the intervention can be published. It is provided to the researchers to conduct further research. When: The data will be available after the publication of the article. To whom: Researchers working in academic and scientific institutions Conditions: In meta-analysis studies and conducting similar studies Where to obtain: Refer to the Research and Technology Vice-Chancellor of Jundishapur University of Medical Sciences, Ahvaz. While submitting the proposal and obtaining the code of ethics from the ethics committee of this university, access to this data should be provided for the researchers. How to obtain: Researchers can access the data through correspondence with the research and technology unit of the university and since obtaining the code of ethics from the research ethics committee of Jundishapur University of Medical Sciences, Ahvaz. Comments:
public Dr. Mustafa Ariafar
Atherosclerosis Research Center, Jundishapur University, Ahvaz
Ahvaz Iran (Islamic Republic of) 1635733118 +98 61 3374 3966 ariafar-m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Parvin Ghorbani
Farvardin Boulevard, Ahvaz Golestan Hospital
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3320 4501 ghorbani_pary66@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Those who are willing to participate in the study Patients whose clinical information is complete Patients whose disease has been confirmed as STEMI and are candidates for angiography and angioplasty 18 years no limit Both Patients who do not agree to participate in the study Patients whose clinical information is not complete Patients with heart failure Dialysis patients who do not pass urine I21.9 Acute myocardial infarction,unspecified Prevention Prevention Intervention group: Recipients of 0.5 mg/kg formeside within one hour after Percutaneous Coronary Intervention (PCI) as a single dose and 1 mg/kg/h of normal saline serum within 24 hours after Percutaneous Coronary Intervention (PCI) Control group: recipient of normal saline at the rate of 1 mg/kg/h during 24 hours after Percutaneous Coronary Intervention (PCI) Renal function and occurrence of renal disorders after the use of contrast. Timepoint: After a period of 24 and 72 hours after the injection of furosemide and serum. Method of measurement: Test: Blood Urea Nitrogen(Bun),Creatinine(Cr), Glomerular Filtration Rate (GFR). Jundishapur University of Medical Sciences, Ahvaz Approved 2022-09-19 Research Ethics Committee of Golestan Hospital, Ahvaz University of Medical Sciences Farvardin Blvd Ahvaz Khouzestan Iran (Islamic Republic of)