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IRCT20151227025726N11 IRCT 2018-12-02 Shahid Beheshti University of Medical Sciences Evaluating the effect of melatonin on the prevention of postoperative atrial fibrillation and acute kidney and injury following open heart surgery Evaluating the effect of melatonin on the prevention of postoperative atrial fibrillation and acute kidney and injury (AKI) following coronary artery bypass grafting (CABG) surgery 2018-04-03 anticipated 70 Complete https://irct.ir/trial/29487 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization method using table of random numbers is applied to the study population. Unit of randomization is individual. Even and odd numbers are chosen for the case and the control group, respectively. Numbered drug containers are applied for allocation concealment. 3 Condition 1: Atrial fibrillation. Condition 2: Acute kidney injury. Intervention 1: Intervention group: Administration of 12 mg sublingual melatonin tablets the night before and one hour before surgery. Intervention 2: Control group: will not receive the drug. 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 A definite decision about the publication of the patients data is not made regarding patients privacy and ethics
public Saghar Barati
ُShahid Beheshti Faculty of Pharmacy, Niayesh Highway, Valiasr Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 sgh_brt68@yahoo.com Shahid Beheshti University of Medical Sciences scientific Farzaneh Dastan
Shahid Beheshti Faculty of Pharmacy, Niayesh Highway, Valiasr Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 f_dastan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) patients who are candidates for elective CABG surgery in in a tertiary referral center no limit no limit Both a need for valvular surgery along with CABG surgery history of any supraventricular arrhythmias history of taking any antiarrhythmic agents except for beta blockers,calcium channel blockers and cardiac glycosides history of epilepsy or seizure disorders history of cerebrovascular disorders history of sleep pattern disorders history of taking any drug affecting sleep pattern including benzodiazepines, antidepressants,antipsychotics, dopamin agonists and beta agonists history of autoimmune disorders chronic hepatic failure ( liver enzymes rises more than 3 times the upper limit of normal) Chronic kidney disease (Stage IV & V) or patients with Glomerular Filtration Rate of lower than 30 ml/min history of taking anti inflammatory agents within 2 weeks of admission except for statins patients undergoing CABG surgery emergently patients receiving magnesium 148.9 N99.9 Atrial fibrillation and atrial flutter, unspecified Postprocedural disorder of genitourinary system, unspecified Prevention Prevention Intervention group: Administration of 12 mg sublingual melatonin tablets the night before and one hour before surgery. Control group: will not receive the drug Creatinine plasma LEVEL. Timepoint: Before surgery, first, second, third, fourth and fifth day after surgery. Method of measurement: ELISA. Hs-CRP plasma LEVEL. Timepoint: Before surgery and 24 hours after surgery. Method of measurement: ELISA. Incidence of atrial fibrillation. Timepoint: After surgery until 7 days. Method of measurement: Questionnaire. Incidence of cardiac inflammation and injury. Timepoint: Before and 24 hours after surgery. Method of measurement: Measuring the amount of CK-MB and Troponin biomarker elevation in plasma sample by their kits. Shahid Beheshti University of Medical Sciences Approved 2018-07-01 Ethics Committee of Shahid Beheshti University of Medical Sciences ,Pharmacy Faculty Intersection of Niyayesh Highway, Valieasr St., Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy Tehran Tehran Iran (Islamic Republic of)