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IRCT20230110057096N1 IRCT 2023-02-10 Rasht University of Medical Sciences Effect of Nicorandil on contrast-induced nephropathy Evaluation of efficacy of Nicorandil on incidence of contrast-induced nephropathy in patients with GFR < 60% and undergoing coronary angiography and percutaneous coronary intervention- A randomized clinical trial 2023-02-04 anticipated 264 Complete https://irct.ir/trial/68002 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The method of sampling and randomization of this clinical trial study will be the blocked randomization method. In this way, each person will be randomly placed in the intervention and control group using blocks of 4 randomly in a ratio of 1:1. Letters A and B will be assigned to each group. The website http://www.randomization.com/ will be used for randomization. The list of codes obtained from this website will be provided to the researchers of the project, and every patient who meets the conditions for entering the study will be entered into the study according to the assigned code A, B respectively. For concealment in this research, simple random allocation concealment method will be used on the study participants. In this way, each patient will be assigned a code. In this method, each of the generated random codes will be written on a card. Then they will be placed inside sealed opaque envelopes in random order. In order to maintain the random sequence, the outer surface of the envelopes will be numbered in the same order. Finally, the lid of the letter envelopes will be glued and will be placed in a box respectively. At the time of sampling, based on the order of entry of qualified participants into the study, one of the envelopes will be revealed in the order of opening and the assigned group of that participant, Blinding description: Our study will be one-sided blind. Due to ethical issues, we cannot hide the type of treatment from the patients, so the patients are aware of the type of treatment they will receive (being in the intervention or control group). But to avoid bias in the results, the outcome evaluator (data analyst) does not know which groups the patients belong to. The groups can be specified by coding so that the analyst does not understand. 3 contrast-induced nephropathy. Intervention 1: Control group: In the control group standardad treatment is used and we do not use placebo. as standard treatment tab NAC 1200 mg/po/BD is given to the patients. we also hydrate the patients with half saline 50cc/h from 24 hours before to 24 hours after the procedure . we use NAC from SanaMed pharmaceutical co. Intervention 2: Intervention group: in the intervention group as standard treatment tab NAC 1200 mg/po/BD is given to the patients. we also hydrate the patients with half saline 50cc/h from 24 hours before to 24 hours after the procedure . also tab Nicorandil 10 mg/po/BD is given to the patients from 24 hours before to 24 hours after the procedure. we use NAC from SanaMed pharmaceutical co. and Nicorandil from rivopharm. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Arsalan Salari
Next to the management and planning organization of Gilan province, 15 Khordad st., Rasht
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 9064 gums.icrc@gmail.com Rasht University of Medical Sciences scientific Arsalan Salari
Next to the management and planning organization of Gilan province, 15 Khordad st., Rasht
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 9064 gums.icrc@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with GFR<60 ml/min that do not undergo dialysis Patients who are a candidate for non-emergent CAG or non-primary PCI and have 24-hour time for treatment with Nicorandil no limit no limit Both Consuming Metformin, ACEI, ARB, Nicorandil, Nitrocontin, Sildenafil and other phosphodiesterase 5 inhibitors in the last 24 hours having urinary tract infection(UTI) ICD 10- N1 Nephropathy induced by other drugs, medicaments and biological substances Prevention Prevention Control group: In the control group standardad treatment is used and we do not use placebo. as standard treatment tab NAC 1200 mg/po/BD is given to the patients. we also hydrate the patients with half saline 50cc/h from 24 hours before to 24 hours after the procedure . we use NAC from SanaMed pharmaceutical co. Intervention group: in the intervention group as standard treatment tab NAC 1200 mg/po/BD is given to the patients. we also hydrate the patients with half saline 50cc/h from 24 hours before to 24 hours after the procedure . also tab Nicorandil 10 mg/po/BD is given to the patients from 24 hours before to 24 hours after the procedure. we use NAC from SanaMed pharmaceutical co. and Nicorandil from rivopharm Creatinine level. Timepoint: Measuring level of creatinine on the days 0-3-5. Method of measurement: Creatinine measurement will be done with the help of a quantitative detection kit for creatinine in serum, plasma or urine with the photometric method of Pars Azmoun company and with the callimetric method without removing proteins based on the JAFFE method. BUN level. Timepoint: Measuring level of BUN on the days 0-3-5. Method of measurement: BUN will be measured with the help of Urea UV quantitative detection kit in serum, plasma and urine with the photometric method of Pars Azmoun company and with the enzyme method based on the Urease-GLDH method. Urinary output. Timepoint: Measuring urinary output on the days 0-3-5. Method of measurement: The amount of urinary output is calculated by measuring the volume of a person's urine. Rasht University of Medical Sciences Approved 2022-12-21 Ethics committee in research of Guilan University of Medical Sciences Vice President of Research and Technology of Guilan University of Medical Sciences, in front of 17sharivar Hospital,Shahid Siadati Ave., Namjoo Blvd., Rasht, Guilan Rasht Guilan Iran (Islamic Republic of)