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IRCT20180820040838N1 IRCT 2018-10-01 Bandare-abbas University of Medical Sciences Effect of induced muscle ischemia on kidney injury Evaluation of protective effect of induced muscle ischemia on contrast induced acute kidney injury (CI-AKI) after cardiac angiography or Percutaneous Coronary Intervention (PCI) in cardiac patient admitted at Shahid Mohammadi hospital in 2017-2018 2016-11-21 anticipated 140 Complete https://irct.ir/trial/33756 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Method of randomization: simple, Unit of randomization: individual, Tools used in randomization such as table of random numbers, Blinding description: This is a double-blind study in which patients and outcomes analyzer are blinded. In order to blind the patient, in both groups, it is said that RIPC protocol is being used. In order to blind the analyzer, the persons responsible for executing 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. Sanaz Soleymani, +98 917 367 9262, sanazsoleymani9262@gmail.com. How to obtain: Upon authentication, data is provided to the individual. Comments:
public Sanaz Soleymani
Islamic Republic Blvd
Bandare-abbas Iran (Islamic Republic of) 7916613885 +98 76 3333 3280 sanazsoleymani9262@gmail.com Bandare-abbas University of Medical Sciences scientific Hamidreza Samimagham
Islamic Republic Blvd
Bandare-abbas Iran (Islamic Republic of) 7916643885 +98 76 3333 3280 sanazsoleymani9262@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Age equal or greater than 18 years Hospitalized patients requiring angiography or PCI 18 years no limit Both Patients who did not have consent to participate in the study Patients with renal dysfunction (GFR <60) based on KDIGO criteria Pregnant patients Patients who used nephrotoxic drugs 72 hours before angiography or PCI Patients who needed an emergency angiography or PCI Patients with cardiogenic shock, recent cardiac infarction or EF < 50% N17 Acute renal 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. Urine Neutrophil gelatinase-associated lipocalin (NGAL). Timepoint: Before intervention and 6 hours 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: Modification of diet in renal diseases (MDRD) GFR Equation. Acute Kidney Injury (AKI). Timepoint: After intervention. 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, Islamic Republic blvd. Bandare-abbas Hormozgan Iran (Islamic Republic of)