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IRCT20170609034406N11 IRCT 2024-01-25 Tabriz University of Medical Sciences Effect of Dapagliflozin in The Prevention of Iodinated Contrast Media Induced Acute Kidney Injury Effect of Dapagliflozin in The Prevention of Acute Kidney Injury Caused by Iodinated Contrast Media: A Randomized Placebo-Controlled Clinical Trial 2023-12-27 anticipated 80 Complete https://irct.ir/trial/74023 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted Block Randomization method will be used to assign patients into two treatment and control groups.This study will have 20 blocks equally containing 4 patients allocated to treatment and control group. Random numbers in this study will be generated using Excel software to determine coalitions, and study groups randomly, Blinding description: This study will be conducted in a double-blind manner, none of the prescribers and patients and investigator and outcome assessor and data collectors will know which of the patients received Dapagliflozin or placebo , and only through the numbers provided by the system was given to patients, it will be diagnosed. 3 Acute kidney injury caused by iodinated contrast agents. Intervention 1: Intervention group (Dapagliflozin + standard care): 40 patients will be included in the study according to the inclusion and exclusion criteria, and will recieve 10 mg of Dapagliflozin once daily from 3 days before to 2 days after the receiving iodinated contrast agent along with the standard care recommended by the Iranian Ministry of Health protocol. Intervention 2: Control group (Placebo + standard care): 40 patients will be included in the study according to the inclusion and exclusion criteria, and will recieve the equivalent placebo of 10 mg of Dapagliflozin once daily from 3 days before to 2 days after receiving the iodinated contrast agent along with the standard care recommended by the Iranian Ministry of Health protocol. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Afshin Gharekhani
No 2 central building, Tabriz University of Medical Science, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 0098413372250 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Afshin Gharekhani
No 2 central building, Tabriz University of Medical Science, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3337 2250 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Adults aged 18 years or older Patients who are candidates for CT scan and receive Iodized Contrast Agents 18 years no limit Both Patients with underlying renal failure with GFR less than 30 Patients with liver failure (Child-Pugh stage B and C) Patients with heart failure Pregnant and lactating women The presence of chronic infection or autoimmune diseases History of taking Dapagliflozin Diabetic patients with Diabetic foot ulcers Patients are susceptible to ketoacidosis Alcoholic patients Patients with pancreatic failure History of allergy to Dapagliflozin Patients with osteoporosis Concomitant use of nephrotoxic drugs such as Calcineurin Inhibitors , Aminoglycosides, Vancomycin, Amphotericin B Participation in other clinical studuies N17 Acute kidney failure Treatment - Drugs Placebo Intervention group (Dapagliflozin + standard care): 40 patients will be included in the study according to the inclusion and exclusion criteria, and will recieve 10 mg of Dapagliflozin once daily from 3 days before to 2 days after the receiving iodinated contrast agent along with the standard care recommended by the Iranian Ministry of Health protocol. Control group (Placebo + standard care): 40 patients will be included in the study according to the inclusion and exclusion criteria, and will recieve the equivalent placebo of 10 mg of Dapagliflozin once daily from 3 days before to 2 days after receiving the iodinated contrast agent along with the standard care recommended by the Iranian Ministry of Health protocol. Urine KIM1 (Kidney Injury Molecule-1) level. Timepoint: At the beginning and end of the study. Method of measurement: ELISA Kit. Serum BUN (Blood urea nitrogen) and Creatinine level. Timepoint: At the beginning and end of the study. Method of measurement: AutoAnalyzer. Urine and Serum NGAL(Neutrophil Gelatinase Associated Lipocalin) level. Timepoint: At the beginning and end of the study. Method of measurement: ELISA Kit. Tabriz University of Medical Sciences Approved 2023-11-19 Research Ethics Committees of Faculty of Pharmacy - Tabriz University of Medical Science Research Ethics Committees , 4th floor, Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishaburi, Golgasht St, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)