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IRCT20120703010178N21 IRCT 2020-11-14 Shahid Beheshti University of Medical Sciences evaluation of colchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS): Investigation of colchicine effect on the post-pericardiotomy syndrome alleviation:a randomized, double blinded, placebo controlled study 2020-02-20 anticipated 100 Complete https://irct.ir/trial/49516 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization was done by block randomization method using a randomization table made with statistical software with four blocks and individual randomization unit. To hide this table, there is only one copy of this table without specifying the study groups that are maintained by the study host in the center, Blinding description: In this study, due to the use of tablets of similar weight and appearance and similar drug canisters, drugs and placebo can not be distinguished from each other. Medications are given with three-character codes, including two letters and one number. A cardiologist who introduces the patient to the study does not know what drug will be deliver to the patient. Due to the fact that it is not included in the randomization list of the study groups, the drug deliverer is blind to the delivered drug and, given the very similar appearance of the drug and the placebo, there is no way to determine the type of drug delivery for the patient and the investigator. The assessor is a self-delivering scholar who does not know the patient group. Only one person outside the study has a list of groups for each group, which only provides the original researcher if there is a report of serious side effect or the completion of study. 3 Post-pericardiotomy Syndrome. Intervention 1: Forty-eight hours before surgery, subjects in the intervention group will receive colchicine (Modava pharmaceuticals, Iran) two tablets (equal to 1mg colchicine) every 12 hours for 48 hours and then 1 tablet (equal to 0.5mg) twice daily for two weeks thereafter. Intervention 2: Forty-eight hours before surgery, subjects in the control group will receive identical placebo (Modava pharmaceuticals, Iran) two tablets every 12 hours for 48 hours and then 1 tablet twice a day for two weeks thereafter. Yes - There is a plan to make this available What will be shared: Individual data will be shared: Demographic information,post precardiotoy syndrom frequency baseline cardiac function information, concomitant drugs and concomitant illnesses, reported infections. When: Staring6 months after completion of sampling To whom: The information will be accessible to all categories by reviewing the applicant's eligibility. Conditions: The sending person may include patients, legislators, researchers, university professors and students. Where to obtain: Applicants must send their application along with the reason for the need for the study data to the principle investigator's email address. mohamad sistanizad e mail sistanizadm@sbmu.ac.ir How to obtain: The request is evaluated within 2 weeks by the principal investigator and will be sent to the person or institution requested Comments:
public Mohammad Sistanizad
Madani Ave, Tehran, Iran
تهران Iran (Islamic Republic of) 1946614893 +98912274895 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Reza miri
Imam hossein hospital,shahid madani Ave.
Tehran Iran (Islamic Republic of) 1617763141 0098 21 73430 reza-miri78@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients undergoing cardiac surgery, had no contraindication to colchicine, were able to provide informed consent. candidate for cardiac surgery by cardiologist age ≥18 years patients have to be willing and able to give informed consent and to comply with the study and follow-up. 18 years no limit Both known myopathy or elevated baseline pre-operative creatine kinase Liver problems serum creatinine upper than 2.5mg/dl Gastrointestinal problems pregnancy or OCP usage hypersensitivity to colchicine I31.9 Disease of pericardium, unspecified Treatment - Drugs Placebo Forty-eight hours before surgery, subjects in the intervention group will receive colchicine (Modava pharmaceuticals, Iran) two tablets (equal to 1mg colchicine) every 12 hours for 48 hours and then 1 tablet (equal to 0.5mg) twice daily for two weeks thereafter. Forty-eight hours before surgery, subjects in the control group will receive identical placebo (Modava pharmaceuticals, Iran) two tablets every 12 hours for 48 hours and then 1 tablet twice a day for two weeks thereafter. The occurrence of post-pericardiotomy syndrome ( PPS):. Timepoint: 2 days before surgery,till 2weeks ,after it. Method of measurement: physical examination-echocardiography PPS confirms when at least two of the following parameters occur simultaneously: 1- Fever: 2-3 weeks post-operative without evidence of systemic or focal infection; 2- Pleuritic chest pain; 3-Friction rub; 4- Evidence of pleural or pericardial effusion. The secondary endpoint was the combined rate of disease-related rehospitalization, cardiac tamponade, constrictive pericarditis,and recurrent pericarditis. Timepoint: During first 14 days after cardiac surgery or hospitalization period. Method of measurement: echocardiography-physical examination. Shahid Beheshti University of Medical Sciences Approved 2020-01-13 Shahid Beheshti University of Medical Sciences Velenjak Street, Shahid Chamran High Way tehran Tehran Iran (Islamic Republic of)