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IRCT20210620051631N1 IRCT 2021-12-19 Mashhad University of Medical Sciences Evaluation of the oral Nicorandil effect on reducing the contrast-induced Evaluation of the oral Nicorandil effect on reducing the contrast-induced nephropathy incidence in cardiac catheterization patients: a randomized controlled clinical trial 2021-12-22 anticipated 344 Complete https://irct.ir/trial/59561 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This is how the envelopes will be prepared and printed by one of the research team members, and random numbers with the help of the Randomaize.com site will be placed inside the envelope. The lid of the envelope will be closed and its contents will not be visible from the outside. Then, the purpose of the study is first explained to the person who meets the conditions, and the person, if desired, signs the informed consent form and takes an envelope, and then opens it and enters the intervention or control group based on the contents of the envelope, Blinding description: The subjects and those evaluating the outcome will be unaware of the intervention and control groups. Eligible patients are divided into control and intervention groups (nicorandil) using a list of random numbers. Those who evaluate the outcome consist of people who work at the center and have no knowledge of the researchers' research and will make a secret assignment for the research themselves. 3 cardiac catheterization. Intervention 1: Intervention group: from 2 hours before to 24 to 48 hours after the procedure, oral nicorandil 10 mg 3 times a day, and intravenous normal saline from 2 hours before to 6 hours after the procedure are given to patients. Intervention 2: Control group: In the control group, intravenous normal saline (1 ml / kg / hr) was given to patients from 2 hours before to 6 hours after the procedure. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After finishing work, consult with colleagues and it will be published if all members
public Alireza Abdollahimoghaddam
imamreza hospital
Mashhad Iran (Islamic Republic of) 13944_91388 +98 51 3843 6827 alavisadegh157@gmail.com Mashhad University of Medical Sciences scientific Sadegh Alavi
Ahmadabad St. Shariati Sq. Imam Reza Hospital
Mashhad Iran (Islamic Republic of) 13944_91388 +98 51 3843 6287 alavisadegh157@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Based on the risk score,Have a moderate risk or at least two risk factors for contrast nephropathy. EF less than 40 Diabetes mellitus. Blood pressure above 140/90 mm Hg, Renal failure (GFR) less than 60 No pregnancy (basal serum creatinine above 1.5 mg / dl) Minimum age 18 18 years no limit Both Pregnancy Pulmonary edema Cardiogenic shock Multiple myeloma Acute renal failure ESRD(GFR<15 mg/dl) Allergy to media contrast Nicorandil allergy Facing media contrast in the last 7 days NAC and metformin and dopamine and sodium bicarbonate and mannitol and phenol dopam in the last 48 hours Treatment - Other Treatment - Other Intervention group: from 2 hours before to 24 to 48 hours after the procedure, oral nicorandil 10 mg 3 times a day, and intravenous normal saline from 2 hours before to 6 hours after the procedure are given to patients. Control group: In the control group, intravenous normal saline (1 ml / kg / hr) was given to patients from 2 hours before to 6 hours after the procedure. Laboratory banksHb, FBS, HCT, TG, LDL, HDL,ChoL. Timepoint: The first step at the beginning of the study. Method of measurement: Sampling. Serum creatinine and creatinine clearance and BUN. Timepoint: It is measured 24 to 48 hours after the procedure. Method of measurement: Protocol based analysis. Mashhad University of Medical Sciences Approved 2021-03-14 Ethics committee of Mashhad University of Medical Sciences Imam Reza Hospital Square. Imam Reza Hospital Mashhad Razavi Khorasan Iran (Islamic Republic of)