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IRCT20201028049175N4 IRCT 2021-01-16 Arak University of Medical Sciences : Prophylactic effect of vitamin D supplementation in the prevention of atrial fibrillation after coronary artery bypass grafting : Randomized Clinical Trial : Prophylactic effect of vitamin D supplementation in the prevention of atrial fibrillation after coronary artery bypass grafting : Randomized Clinical Trial 2021-01-29 anticipated 90 Complete https://irct.ir/trial/53652 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of specific codes that are obtained by the website, Blinding description: All of patients and the person who will fill the check lists are unaware about dosage of the drugs and drugs will be prescripted by the anesthesiologist 72 hours before the surgery. 2 Condition 1: Atrial fibrillation after CABG. Condition 2: Atrial fibrillation after CABG. Intervention 1: Intervention group: In group A 300000 IU of vit D (equivalent of 2 cc of 300000 IU vial) will be given to the patients 72 hours before the surgery. Intervention 2: Intervention group: In group B 480000 IU of vit D (equivalent of 2 cc of 480000 IU vial) will be given to the patients 72 hours before the surgery. Intervention 3: Intervention group: In group C 600000 IU of vit D (equivalent of 2 cc of 600000 IU vial) will be given to the patients 72 hours before the surgery. 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 There are no more data.
public Alireza Kamali
Valiasr hospital, Valiasr square
Arak Iran (Islamic Republic of) 3814957558 086-32222003-8 alikamaliir@yahoo.com Arak University of Medical Sciences scientific Alireza Rostami
Amiralmomenin hospital street, Basij square
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3601 dr_ar_rostami@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients who are condidated for elective CABG that have informed consent for joining to the study. All patients that duration of their surgery is less than 6 hours. Serum level of vit D less than 30 nanomol per litr 45 years 80 years Both History of having arrhythmia and atrial fibrillation History of using antiarrhythmic drugs in class I and III or Digoxin History of having permanent or temporary heart pace maker History of atrioventricular block or bradycardia with less than 50 heart beat per minute History of severe kidney or pulmonary (pneumonia or chronic obstractive pulmonary disease ) or liver (cirrhosis or fulminant hepatitis) disease Non elective CABG Patients who need heart valve replacement surgery, in addition to CABG I48.0 T82.9 Paroxysmal atrial fibrillation Unspecified complication of cardiac and vascular prosthetic device, implant and graft Prevention Prevention Prevention Intervention group: In group A 300000 IU of vit D (equivalent of 2 cc of 300000 IU vial) will be given to the patients 72 hours before the surgery. Intervention group: In group B 480000 IU of vit D (equivalent of 2 cc of 480000 IU vial) will be given to the patients 72 hours before the surgery. Intervention group: In group C 600000 IU of vit D (equivalent of 2 cc of 600000 IU vial) will be given to the patients 72 hours before the surgery. Frequency of post CABG atrial fibrillation. Timepoint: From the end of surgery untill 72 hours after surgery. Method of measurement: heart monitoring. Arak University of Medical Sciences Approved 2019-06-16 Ethics committee of Arak University of Medical Sciences Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square Arak Markazi Iran (Islamic Republic of)