Investigation of colchicine effect on the post-pericardiotomy syndrome alleviation:a randomized, double blinded, placebo controlled study

: Investigation of colchicine effect on incidence of the post-pericardiotomy syndrome

A randomized, parallel group, double blinde, placebo controlled trial ,100 cardiac surgery candidates

This study was conducted at cardiology Clinic of Imam Hussein Hospital. Patients are candidate for cardiac surgery by specialist if they are qualified to enter into the study. After complete information about the study is provided to the patients, drug/placebo will be delivered to the patient if agreed. past medical history ,Laboratory tests included CBC, , AST, ALT, Alp, BUN, Cr,CPK ,echocardiography will done. the incidence of post-pericardiotomy syndrome at 2 week after surgery will evaluated.

Inclusion criteria were: candidate age ≥18 years, Patient agrees to enter the study exclusion criteria were not eligible liver functional test>1.5 times the upper normal limit Abnormal creatinine2.5mg/dl known myopathy elevated CPK gastrointestinal disease hypersensitivity to colchicine,

cases: 50 cases, were treated for 48 hours pre-operation, with 1 mg colchicine ; one-dose each 12 hours for first two days. After surgery, patients were treated with 0.5 mg colchicine each 12 hour for 2 weeks. control: 50 patients, were treated for 48 hours pre-operation, with each 12 hours for first two days. After surgery, patients were treated with placebo each 12 hour for two weeks. After two weeks the PPS syndrome occurence were evaluated

the incidence of the PPS (Fever lasting beyond the first post-operative week without evidence of systemic or focal infection,Pleuritic chest pain,Friction rub,Evidence of pleural effusion,Evidence of pericardial effusion) the combined rate of disease-related hospitalization, cardiac tamponade, constrictive pericarditis, and recurrent pericarditis.

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.

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.

Individual data will be shared: Demographic information,post precardiotoy syndrom frequency baseline cardiac function information, concomitant drugs and concomitant illnesses, reported infections.

Staring6 months after completion of sampling

The information will be accessible to all categories by reviewing the applicant's eligibility.

The sending person may include patients, legislators, researchers, university professors and students.

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

The request is evaluated within 2 weeks by the principal investigator and will be sent to the person or institution requested