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IRCT20250901067077N1 IRCT 2025-10-24 Pasture Institute of Iran Administration of liver and kidney protective agent The effect of intravenous administration of N-acetylcysteine during cardiopulmonary bypass on hepatic and renal function and cardiac enzymes in patients undergoing coronary artery bypass surgery 2025-10-18 anticipated 66 Complete https://irct.ir/trial/86864 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study is a single-blind clinical trial in which block randomization will be used for the allocation of subjects, and the patients will be unaware of the type of intervention. This research will be conducted on patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB) at Shahid Rajaei Cardiovascular, Medical, Research, and Training Center in the year 2025 (1404 Iranian calendar). Data will be collected using data collection forms (attached) containing clinical information extracted from patients’ medical records, including name, surname, age, sex, height, weight, diagnosis, type of surgery, attending physician and surgeon, as well as clinical outcome results. To identify eligible participants, the researcher will obtain a list of medical records of patients scheduled for Tetralogy of Fallot surgery from the relevant department heads. Then, based on a review of these medical records, patients who meet the inclusion criteria will be continuously recruited as study samples, Blinding description: This study is single-blind, in which the clinical caregiver is unaware of the intervention procedure. 3 Patients with coronary artery involvement. Intervention 1: Intervention group:Intervention group: Patients will be randomly divided into two groups receiving N-acetylcysteine ​​and a control group. Patients in the receiving group will receive 100mg/kg N-acetylcysteine ​​ampoule in prime solution and 100mg/kg before cross-clamp removal. Intervention 2: Control group:Control group: Patients in the control group will not receive any intervention. ABG will also be monitored every hour during the pump and every 6 hours after the operation. All stages of anesthesia, operation, and cooling and warming are performed identically in both groups. The location of this study is the operating room and intensive care unit of Shahid Rajaee Heart Hospital. 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 No more information
public Ali Kheyabadi
Valiasr Avenue (A.S.) ,Next to Mellat Park , at the corner of Niayesh , Shahid Rajaei Cardiovascular, Medical, Research, and Training Institute
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 kheirabadia931@gmail.com Shahid Rajaei Cardiovascular, Medical, Research, and Training Institute scientific Ali Kheyrabadi
Valiasr Avenue (A.S.) , Next to Mellat Park , at the corner of Niayesh , Shahid Rajaei Cardiovascular, Medical, Research, and Training Institute
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 kheirabadia931@gmail.com Shahid Rajaei Cardiovascular, Medical, Research, and Training Institute Iran (Islamic Republic of) All adult patients (over 18 years of age) undergoing first-time elective coronary artery bypass graft (CABG) surgery. Patients with a left ventricular ejection fraction (LVEF) of 30% or higher. 18 years no limit Both I25.1 Treatment - Drugs Treatment - Drugs Intervention group:Intervention group: Patients will be randomly divided into two groups receiving N-acetylcysteine ​​and a control group. Patients in the receiving group will receive 100mg/kg N-acetylcysteine ​​ampoule in prime solution and 100mg/kg before cross-clamp removal. Control group:Control group: Patients in the control group will not receive any intervention. ABG will also be monitored every hour during the pump and every 6 hours after the operation. All stages of anesthesia, operation, and cooling and warming are performed identically in both groups. The location of this study is the operating room and intensive care unit of Shahid Rajaee Heart Hospital. Postoperative cardiac enzyme levels are lower in the intervention group. Timepoint: Evaluation of patients’ liver function tests (LFTs) before and after surgery – assessment of reoperation due to bleeding – evaluation of inotropes used during surgery and within 24 hours after ICU admission. Method of measurement: The measurement of cardiac enzymes is performed using the corresponding laboratory test kits. Reduction in length of stay in the intensive care unit (ICU). Timepoint: The time points for measuring the length of hospital stay as a secondary outcome are 48 to 72 hours postoperatively. Method of measurement: The method of measurement is based on the corresponding checklist. Pasture Institute of Iran Approved 2025-07-06 Ethics committee of Cardiovascular Research Center, Rajaie Cardiovascular Institute Valiasr Avenue (A.S.) – Next to Mellat Park – at the corner of Niayesh – Shahid Rajaei Cardiovascular, Medical, Research, and Training Institute Tehran Tehran Iran (Islamic Republic of)