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IRCT2017110537254N1 IRCT 2017-11-09 Vice chancellery for research affairs, Shiraz University of Medical Sciences Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Trial 2013-11-02 anticipated 180 Complete https://irct.ir/trial/27605 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A Condition 1: Acute kidney injury. Condition 2: Remote ischemic preconditioning. Condition 3: Coronary artery bypass graft surgery. Intervention 1: Intervention: RIPC Patients in the remote ischemic preconditioning (RIPC) group will receive three sequential sphygmomanometer cuff inflations on their right upper arm after induction of anesthesia in the operating room. The cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with five minutes deflation in between inflations. Following this pre-conditioning phase, surgery will be started. The entire pre-conditioning phase will last 30 minutes. Intervention 2: Control: sham-RIPC Patients in the sham-RIPC group will have the sphygmomanometer cuff placed on their right upper arm, but the cuff will not be inflated. Similar to patients in the RIPC group, patients in the sham-RIPC group will undergo the same 30 minute delay before starting surgery.
public Sina Bagheri
Room No. 5, Floor 6, Mohammad Rasool Allah Research Tower, Khalili street, Mulla Sadra Blvd
Shiraz Iran (Islamic Republic of) +98 71326281563 bagherisi@sums.ac.ir Shiraz nephro-urology research center scientific Mohammad Mahdi Sagheb
Room No. 5, Floor 6, Mohammad Rasool Allah Research Tower, Khalili street, Mulla Sadra Blvd
Shiraz Iran (Islamic Republic of) +98 71326281563 saghebm@sums.ac.ir Shiraz Nephro Urology Research Center Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion Criteria: • Candidate cardiac surgical patients • Elective or urgent on pump coronary artery bypass grafting (CABG) • Age 18 to 85 years • Signed informed consent Exclusion Criteria: • End-stage renal disease (receiving hemodialysis or glomerular filtration rate <15 ml/min/1.73m2) • Peripheral vascular disease • Severe hepatic disease • Planned off-pump surgery • Pregnancy 18 years 85 years Both Prevention Placebo Intervention: RIPC Patients in the remote ischemic preconditioning (RIPC) group will receive three sequential sphygmomanometer cuff inflations on their right upper arm after induction of anesthesia in the operating room. The cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with five minutes deflation in between inflations. Following this pre-conditioning phase, surgery will be started. The entire pre-conditioning phase will last 30 minutes. Control: sham-RIPC Patients in the sham-RIPC group will have the sphygmomanometer cuff placed on their right upper arm, but the cuff will not be inflated. Similar to patients in the RIPC group, patients in the sham-RIPC group will undergo the same 30 minute delay before starting surgery. Incidence of postoperative acute kidney injury (AKI). Timepoint: Within the first 72 hours after surgery. Method of measurement: Defined as an elevation of serum creatinine of ≥0.3 mg/dl or ≥50% within 72 hours after surgery. Duration of hospital stay. Timepoint: Through hospital stay after surgery. Method of measurement: in days. Duration of ICU stay. Timepoint: Through ICU stay. Method of measurement: in days. All cause mortality. Timepoint: Through hospital stay after surgery. Method of measurement: number of observed cases. Requiring hemodialysis. Timepoint: Through hospital stay after surgery. Method of measurement: number of observed cases. Postoperative liver function. Timepoint: Preoperatively and at 24 h post-surgery. Method of measurement: By measuring serum AST, ALT, T.bilirubin, and albumin. Incidence of postoperative atrial fibrillation (AF). Timepoint: Within the first 72 hours after surgery. Method of measurement: Defined as the incidence of new-onset AF lasting for five minutes or longer. Incidence of postoperative stroke. Timepoint: Through hospital stay after surgery. Method of measurement: Defined as a new ischemic or hemorrhagic cerebrovascular accident with neurological deficit lasting >24 h. NCT02981680 clinicaltrials.gov Vice chancellery for research affairs, Shiraz University of Medical Sciences Approved 2017-01-23 Ethics Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand Blvd. Shiraz Iran (Islamic Republic of)