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IRCT20211221053477N1 IRCT 2022-09-14 Mazandaran University of Medical Sciences The Effect of Colchicine in prevention of Pericardial Effusion after CABG The Effect of Colchicine in prevention of Pericardial Effusion after CABG, randomized clinical trial 2022-01-21 anticipated 260 Complete https://irct.ir/trial/61073 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomly, by block method (Block Random Allocation) with variable block sizes (multiples of 2) and using randomizer software, they will be divided into two groups of patients receiving colchicine and the control group. Based on this setting, the drugs prepared They are coded (with two letters and three numbers) and numbered in sequence. During the study, in the order of entry of eligible people into the study, the considered medicine (by number) will be provided to the patients. After that, all the patient's information will be recorded in the information collection forms based on the code inserted on the medicine (as the patient's identifier), Blinding description: Therapists and evaluators will not be informed of the assignment of individuals to study groups, and the type of medication prescribed. The task of assigning individuals to study groups will be with the research fellow epidemiologist. During the study, in order for the eligible people to enter the study, the intended medicine (according to the number) will be provided to the patients. From then on, all patient information will be recorded in data collection forms based on the code entered on the drug (as a patient identifier). 3 Condition 1: post cabg pericardial effusion. Condition 2: post cabg pericarditis. Intervention 1: Intervention group: Patients in the intervention group will be given 0.5 mg of colchicine every 12 hours for 48 hours before surgery and 0.5 mg daily orally until discharge if they weigh less than 70 kg. befor discharge and two weeks after that, patients undergo transthoracic echocardiography again and the presence or absence of pericardial and pleural effusions is recorded. The drug used in the form of 1 and 0.5 mg tablets produced by the mofid company and under the brand name of Madasin. Intervention 2: Control group: Patients in the control group will be given a placebo similar to the conditions in the intervention group. During discharge and two weeks later, patients will undergo transthoracic echocardiography again and the presence or absence of pericardial and pleural effusions will be recorded. Yes - There is a plan to make this available What will be shared: Apart from the name and contact number, other information about the participants can be published When: Access period starts 6 months after the results are published To whom: This data will be available to researchers working in scientific institutes Conditions: This documentation can be used by researchers and physicians Where to obtain: researchers can access this information by visiting or contacting the research center of Fatemeh Al-Zahra Hospital in Sari How to obtain: After establishing a connection between the research center of Fatemeh Al-Zahra Hospital in Sari and if the eligibility of the applicant is confirmed, the information will be provided to the person within one month. Comments:
public Mohamad Hosein Taghvayi
Artesh street
Sari Iran (Islamic Republic of) 1337148188 011331486 taghvayem@yahoo.com Mazandaran University of Medical Sciences scientific Mohammad hosein Taghvayi
Artesh Blv
Sari Iran (Islamic Republic of) 1337148188 +98 11 4252 4557 taghvayim1372@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) All patients referred to Fatemeh Zahra Heart Hospital with coronary artery disease who are candidates for coronary artery bypass graft surgery no limit 80 years Both Patients over 80 years old Presence of pericardial effusion in preoperative trans-thoracic echo Existence of pleural effusion in CXR standing before surgery Chronic lung, liver disease (known case of liver disease or LFT more than 3 times normal) and kidney disease (known case of kidney disease or Cr> 2.5) Other heart surgeries at the same time as coronary artery bypass grafting Patients who was allergic reaction to colchicine or given colchicine in any way are contraindicated pregnant patients Patients receiving colchicine before starting of study Treatment - Drugs Placebo Intervention group: Patients in the intervention group will be given 0.5 mg of colchicine every 12 hours for 48 hours before surgery and 0.5 mg daily orally until discharge if they weigh less than 70 kg. befor discharge and two weeks after that, patients undergo transthoracic echocardiography again and the presence or absence of pericardial and pleural effusions is recorded. The drug used in the form of 1 and 0.5 mg tablets produced by the mofid company and under the brand name of Madasin. Control group: Patients in the control group will be given a placebo similar to the conditions in the intervention group. During discharge and two weeks later, patients will undergo transthoracic echocardiography again and the presence or absence of pericardial and pleural effusions will be recorded. Pericardial effusion. Timepoint: Before discharg and 14 days after surgery. Method of measurement: echocardiography. Pleural effusion. Timepoint: Before discharge and 14 days after surgery. Method of measurement: echocardography. Pericarditis. Timepoint: Before discharge and 14 days after surgery. Method of measurement: Echocardiography and clinical history. Mazandaran University of Medical Sciences Approved 2022-01-09 ethics committee of mazandaran university of medical sciences artesh street sari Mazandaran Iran (Islamic Republic of)