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IRCT20230719058845N1 IRCT 2023-08-21 Shiraz University of Medical Sciences Comparison of routine del Nido cardioplegia vs two types of modified del Nido cardioplegias for myocardial protection among patients undergoing coronary artery bypass grafting (CABG) surgeries Comparison of routine del Nido cardioplegia vs two types of modified del Nido cardioplegias for myocardialprotection among patients undergoing coronary artery bypass grafting (CABG) surgeries 2023-08-27 anticipated 120 Complete https://irct.ir/trial/71531 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 120 patients will be divided into three groups with 40 individuals in each group. This will be done randomly using block randomization, with a blocked randomization list generated from www.sealedenvelope.com in blocks of 6 (6*20=120), Blinding description: To ensure confidentiality, the treatment allocation will be concealed from study personnel, outcome assessors, and participants. This will be achieved through the use of sequentially numbered sealed opaque envelopes. On the day of the surgery, the perfusionist will receive a sealed envelope with instructions on the cardioplegic solution to prepare and administer according to its specificities before administering anesthesia. To avoid any biases, the surgical team, patients, anesthetists, nurses, and laboratory staff will be blinded to the type of intervention used. After the surgery, the patients will be transferred to the ICU and monitored by a team with post-operative expertise in the specialty, according to standard institutional protocols. The team will also be blinded to the type of cardioplegia used during the surgery. The patients will then be transferred to the postoperative cardiology unit, where they will be managed until hospital discharge by the responsible team, following standard protocols, and also blinded to the type of intervention. The lead investigator, who will identify the outcomes and perform the statistical analyses, will also remain blind to the allocation of patients regarding the type of intervention. During the adjudication process, all researchers will be kept unaware of the patient's allocation to different interventions. The data obtained from the adjudication will be utilized in the final analysis of safety and effectiveness. All data will be evaluated by two authors independently, with quality control on data entry to verify amplitude and consistency. 4 Coronary Artery Disease. Intervention group:. Yes - There is a plan to make this available What will be shared: pdf When: One Month To whom: Students and interested people Conditions: Use in the process of treating patients Where to obtain: To the university library and the person responsible for the study How to obtain: Refer to the university library or refer to the respondent of the study Comments:
public Dr. Mohammad Ghazi Noor
zand street
shiraz Iran (Islamic Republic of) 71936-13311 +98 917 320 9514 ghazinour@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Mohammad Ghazi Noor
zand street
shiraz Iran (Islamic Republic of) 71936-13311 +98 917 320 9514 ghazinour@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients of age more than ۱۸-year-old with minimum ۳۰ % ejection fraction and triple vessel coronary artery disease referred for elective isolated coronary artery bypass grafting (CABG) surgery needing cardiopulmonary bypass will be included . 18 years no limit Both Patients with a history of previous cardiac surgery, chronic renal disease (had a previous medical diagnosis or serum creatinine greater than 1.5 mg/dL), perioperative pregnancy, an implanted pacemaker or intracardiac defibrillator, patient requiring preoperative mechanical support, severe psychiatric illness, and inability or unwillingness to give informed consent for participation will be excluded. For morbid For morbidity, duration as used in categories I21, I22, I24 and I25 refer to the interval elapsing between onset of the ischaemic episode and admission to care. For mortality, duration refers to the interval elapsing between onset and death. Treatment - Surgery Intervention group: Ventricular fibrillation. Timepoint: After removing the aorta clamp. Method of measurement: Electrocardiogram. Troponin and CK-MB Level. Timepoint: Immediately after the operation and 6 hours after the operation. Method of measurement: Lab Data. ICU stay,. Timepoint: The days after the operation. Method of measurement: Number of days of hospitalization. Shiraz University of Medical Sciences Approved 2023-02-01 research ethics committes school of medicine _shiraz uiversity of medical sciences Zand Street, Shiraz University of Medical Sciences shiraz Fars Iran (Islamic Republic of)