]>
IRCT20200825048515N83 IRCT 2025-08-16 Esfahan University of Medical Sciences Relationship between the duration of rewarming patients and the incidence of acute kidney injury after heart surgery Investigating the relationship between the duration of rewarming patients and the incidence of acute kidney injury after coronary artery bypass 2025-09-21 anticipated 80 Complete https://irct.ir/trial/85529 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 80 eligible patients are randomly selected. For this, the letter A is written on 40 sheets, and the letter B is written on 40 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups, Blinding description: In order to comply with the blinding conditions, due to the difference in the intervention method in each group to adjust the speed of rewarming of the patient, the interventionist is aware of the type of intervention in each group. It should be noted that it has also been explained to the patient before including the study that one of the two rewarming methods will be performed for them by chance and they may be placed in one of the two groups and if they consent, they will be entered into the study. Therefore, the patient undergoes this process during surgery and therefore will not be aware of the type of intervention. Also, the person collecting the data and the statistician will not have any knowledge of the type of intervention in each group. 3 Coronary artery bypass surgery. Intervention 1: Intervention group: In this group, patients are cannulated in the ascending aorta and right atrium after systemic heparinization. Cardiopulmonary bypass is performed under mild hypothermia (30°C). Mean arterial pressure is maintained at 80-90 mmHg throughout the coronary artery bypass. After the last distal anastomosis, rewarming is performed to 37°C with a maximum gradient of 10°C between nasopharyngeal temperature and warm water (rapid rate group). Intervention 2: Control group: In this group, patients are cannulated in the ascending aorta and right atrium after systemic heparinization. Cardiopulmonary bypass is performed under mild hypothermia (30°C). Mean arterial pressure is maintained at 80-90 mmHg throughout the coronary artery bypass. After the last distal anastomosis, rewarming is performed to 37°C with a maximum gradient of 5°C between nasopharyngeal temperature and warm water (slow speed group). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Mahmoud Saeidi
Department of Cardiac Surgery, Shahid Chamran Hospital, Mushtaq Street
Isfahan Iran (Islamic Republic of) 81583-88997 +98 31 3260 0961 saeidi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mahmoud Saeidi
Department of Cardiac Surgery, Shahid Chamran Hospital, Mushtaq Street
Isfahan Iran (Islamic Republic of) 81583-88997 +98 31 3260 0961 saeidi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients eligible for elective coronary artery bypass grafting Age range 40 to 75 years EF greater than 40% Written consent to participate in the study 40 years 75 years Both Having a creatinine level more than 1.4 mg/dl before surgery or EGFR < 60 ml/min/1.73 m2 Patients who are candidates for multiple surgeries at the same time (such as valve replacement and Coronary artery bypass) Patients who require emergency surgery Reoperation Having a history of angiography in the last 72 hours Having a history of stroke or any neurological disease Performing dialysis before surgery or chronic chronic kidney disease or a history of any kidney disease I25.810 Atherosclerosis of coronary artery bypass graft(s) without angina pectoris Treatment - Surgery Treatment - Surgery Intervention group: In this group, patients are cannulated in the ascending aorta and right atrium after systemic heparinization. Cardiopulmonary bypass is performed under mild hypothermia (30°C). Mean arterial pressure is maintained at 80-90 mmHg throughout the coronary artery bypass. After the last distal anastomosis, rewarming is performed to 37°C with a maximum gradient of 10°C between nasopharyngeal temperature and warm water (rapid rate group). Control group: In this group, patients are cannulated in the ascending aorta and right atrium after systemic heparinization. Cardiopulmonary bypass is performed under mild hypothermia (30°C). Mean arterial pressure is maintained at 80-90 mmHg throughout the coronary artery bypass. After the last distal anastomosis, rewarming is performed to 37°C with a maximum gradient of 5°C between nasopharyngeal temperature and warm water (slow speed group). Creatinine. Timepoint: Before surgery, the first, second, third, and seventh days after surgery. Method of measurement: Blood test. Urine output. Timepoint: Before surgery, the first, second, third, and seventh days after surgery. Method of measurement: Volume of urine in the urine bag. Glomerular Filtration Rate(GFR). Timepoint: Before surgery, the first, second, third, and seventh days after surgery. Method of measurement: Based on formula: [175 × Serum Cr ^(-1.154)] × [age ^ (-0.203) × 1.212]. Acute kidney injury. Timepoint: After surgery. Method of measurement: Based on the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Isfahan University of Medical Sciences Approved 2025-04-14 Research Ethics Committees of School of Medicine- Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)