The aim of this study is access of effect of vitamin c and placebo on pricardial effusion in post cardiac surgury patients with or without anticoagolation therapy.
In this clinical randomized trial 400 patients (18 years old and older)who had different cardiac surgery (coronary artery bypass,valvular heart surgery,and simple cardiac surgery),divided into two groups,study group who receive vitamin c and control group who receive placebo.Echocardiographic evaluation will be perform for all the patients at the first and 3rd weeks after the cardiac surgery and third weeks we do echocardiography on all patient.
the severity of pericardial effusion will be compared between the two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060713592N1
Registration date:2014-02-11, 1392/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-11, 1392/11/22
Registrant information
Name
Anita Sadeghpour
Name of organization / entity
rajaie cardiovascular medical and research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2145
Email address
asadeghpour@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Rajaie cardiovascular medical and research center,vice chancellor for research
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin c and placebo on pricardial effusion in post cardiac surgury patients with or without anticoagolation therapy
Public title
Effect of vitamin c on pricardial effusion in post cardiac surgury patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient 18 years old and older; different cardiac surgery (coronary artery bypass,valvular heart surgery,and simple congenital cardiac surgery).
Exclusion criteria: patient who expire at the first day of surgery; patient with history of heart and lung transplantation; complex congenital heart disease surgery.
Age
To 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ajaei cardiovascular medical and research center
Street address
Niyayesh, Valiasr Ave.
City
Tehran
Postal code
Approval date
2013-06-18, 1392/03/28
Ethics committee reference number
21089
Health conditions studied
1
Description of health condition studied
pericardial effusion
ICD-10 code
I30
ICD-10 code description
Acute pericarditis
Primary outcomes
1
Description
Amount of pericardial effusion
Timepoint
3 weeks
Method of measurement
Quantitative measurements by transthoracic echocardiography
Secondary outcomes
1
Description
The effect of anticoagulation on pericardial effusion and hospital stay
Timepoint
first 3 weeks after cardiac surgery
Method of measurement
Echocardiography and hospital stay after cardiac surgery
Intervention groups
1
Description
Interventiona Group who receive Vit C, The intervention group received vitamin c 1gr intravenously on the day of surgery and 1 g of oral vitamin C daily for 4 days after surgery.
Category
Treatment - Drugs
2
Description
The control group received placebo who given 1gr saline intravenously on the day of surgery and 1 gr of oral placebo daily for 4 days after surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Reseach center
Full name of responsible person
Anita Sadeghpour
Street address
Rajaie Cardiovascular Medical and Reseach center, Niyayesh, Valiasr Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Anita Sadeghpour
Street address
Niyayesh, Valiasr Ave,.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie Cardiovascular Medical and Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Anita Sadeghpour
Position
Associate professor of cardiology
Other areas of specialty/work
Street address
Rajaie Cardiovascular Medical and Reseach Center, Niyayesh, Valiasr Ave.
City
Tehran
Postal code
Phone
+98 21 2392 2145
Fax
Email
anita.sadeghpour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Anita Sadeghpour
Position
Associate Professor of cardiology
Other areas of specialty/work
Street address
Rajaie Cardiovascular Medical and Reseach Center, Niyayesh, Valiasr Ave.
City
Tehran
Postal code
1996914151
Phone
+98 21 2392 2145
Fax
Email
anita.sadeghpour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Anita Sadeghpour
Position
Associate Professor of cardiology
Other areas of specialty/work
Street address
Rajaie Cardiovascular Medical and Reseach Center, Niyayesh, Valiasr Ave.
City
Tehran
Postal code
Phone
+98 21 2392 2145
Fax
Email
anita.sadeghpour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)