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IRCT20180924041113N1 IRCT 2018-10-30 Bandare-abbas University of Medical Sciences Preventive Effect of induced muscle ischemia on acute kidney injury Evaluation of induced muscle ischemia on prevention of acute kidney injury based on serum cystatin-c in admitted patients undergoing coronary angiography 2017-11-06 anticipated 140 Complete https://irct.ir/trial/34184 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Method of randomization: simple, Unit of randomization: individual, Tools used in randomization: table of random numbers, Patients are randomly divided into two groups of case and placebo by the table derived from Random Allocation software and they are placed in their respective group specified by the software in the order of inclusion in the study. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC533876/), Blinding description: In order to blind the patient, in both groups, the pressure cuff is closed to the patient and in the treatment group, it is inflated up to 200 mm Hg and in the control group up to of 20 mm Hg. In order to blind the analyzer, the persons responsible for executing Remote Ischemic Preconditioning (RIPC) and data collection are different from the outcome assessors. N/A Renal dysfunction. Intervention 1: Intervention group: Remote Ischemic Preconditioning (RIPC) performed via the automated delivery of three cycles of 200 mm Hg blood pressure cuff inflation for 5 min followed by cuff deflation for 5 min on the non-dominant arm. Intervention 2: Control group: sham-RIPC (Remote Ischemic Preconditioning) intervention induced by three cycles of upper-limb pseudo ischemia (low pressure: 5-min blood pressure cuff inflation to a pressure of 20 mmHg and 5-min cuff deflation). Yes - There is a plan to make this available What will be shared: All the patient's data can be shared with privacy in regard to patients name When: Start accessing 6 months after publishing the results. To whom: For scholars working in academic centers. Conditions: It can be analyzed and printed by other people by mentioning the source. Where to obtain: dr. Azadeh Moradkhani,00989121995157,azadeh.moradkhani@yahoo.com How to obtain: Upon authentication, data is provided to the individual. Comments:
public Azadeh Moradkhani
Shahid Mohammadi Hospital, Kuy e Farhangian, Islamic Republic Blvd
Bandare-abbas Iran (Islamic Republic of) 7919915519 +98 76 3375 4950 azadeh.moradkhani@yahoo.com Bandare-abbas University of Medical Sciences scientific Hamidreza Samimagham
Shahid Mohammadi Hospital, Kuy e Farhangian, Islamic Republic Blvd
Bandare-abbas Iran (Islamic Republic of) 7919915519 +98 76 3333 7000 samimagham@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Age equal to or greater than 18 years Hospitalized patients requiring angiography Patients who don’t use nephrotoxic drugs 72 hours before angiography Ejection fraction (EF) > 50% Patients without cardiogenic shock or recent cardiac infarction 18 years no limit Both Patients who did not have consent to participate in the study Patients with renal dysfunction (glomerular filtration rate (GFR) <60) based on KDIGO criteria Pregnant women Patients needing an emergency angiography N17 Acute kidney failure Prevention Placebo Intervention group: Remote Ischemic Preconditioning (RIPC) performed via the automated delivery of three cycles of 200 mm Hg blood pressure cuff inflation for 5 min followed by cuff deflation for 5 min on the non-dominant arm Control group: sham-RIPC (Remote Ischemic Preconditioning) intervention induced by three cycles of upper-limb pseudo ischemia (low pressure: 5-min blood pressure cuff inflation to a pressure of 20 mmHg and 5-min cuff deflation) Serum Creatinine. Timepoint: Before intervention and after intervention daily for 2 days. Method of measurement: AutoAnalyzer. Serum Cystatin-C. Timepoint: Before intervention and 24 hours after intervention. Method of measurement: The enzyme-linked immunosorbent assay (ELISA) kit. Estimated glomerular filtration rate (eGFR). Timepoint: Before intervention and after intervention daily for 2 days. Method of measurement: Glomerular filtration rate Equation. Acute Kidney Injury (AKI). Timepoint: After intervention daily for 2 days. Method of measurement: The 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Bandare-abbas University of Medical Sciences Approved 2017-11-05 Ethics committee of Hormozgan University of Medical Sciences Ethical committee of Hormozgan University of Medical Sciences, Shahid Mohammadi Hospital, Kuye Farhangian, Islamic Republic blvd Bandare-abbas Hormozgan Iran (Islamic Republic of)