Aim of this study is effect of Colchicine in preventing post pericardiotomy syndrome.
Design
This is a clinical trial . 120 patients who underwent open heart surgery in Amiralmomenin Medical Center in Arak city in 2013.
Settings and conduct
This is a clinical trial and double blind. Patients who underwent open heart surgery in Amiralmomenin Medical Center in Arak city in 2013.we divided patients in two groups randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 years and more than; open heart surgery indication
Exclusion criteria: Contraindications for Colchicine; allergy to Colchicine; pregnancy and breastfeeding
Intervention groups
The case group received 1 mg twice a day after the first day of surgery, then 1 milligram daily for 1 month in patients with weight more than 70 kilogram and 0.5 milligram in patients with Weigh less than 70 kilogram.
Control group: The control group received 1 milligram placebo twice a day after the first day of surgery, then 1 milligram daily for 1 month in patients with weight more than 70 kilogram and 0.5 milligram in patients with Weigh less than 70 kilogram.
Main outcome variables
effect of Colchicine in preventing post pericardiotomy syndrome( Incidence Atrial fibrillation and pericardial effusion)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N70
Registration date:2018-03-02, 1396/12/11
Registration timing:retrospective
Last update:2018-03-02, 1396/12/11
Update count:0
Registration date
2018-03-02, 1396/12/11
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Colchicine in preventing post pericardiotomy syndrome
Public title
The effect of Colchicine in preventing post pericardiotomy syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 18 years and more than
open heart surgery indication
Exclusion criteria:
Contraindication for consumption Colchicine
allergy to Colchicine
pregnancy and breastfeeding
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and care provider and data analyzer are unaware of the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
After cardiac surgery, discharge time, one month and six months later
Method of measurement
clinical examination, taking the electrocardiogram and, if necessary, electrocardiography
2
Description
Pericardial effusion
Timepoint
After cardiac surgery, discharge time, one month and six months later
Method of measurement
chest xray and Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The case group received 1 milligram Colchicine twice a day after the first day of surgery, then 1 milligram daily for 1 month in patients with weight more than 70 kilogram and 0.5 milligram in patients with Weigh less than 70 kilogram.
Category
Treatment - Drugs
2
Description
Control group: The case group received 1 milligram placebo twice a day after the first day of surgery, then 1 milligram daily for 1 month in patients with weight more than 70 kilogram and 0.5 milligram in patients with Weigh less than 70 kilogram.