Post operative atrial fibrillation is one of most prevalent complications after cardiac surgery. In this study we try to investigate Ascorbic acid effect on incidence of postoperative atrial fibrillation in patients undergoing coronary artery bypass graft surgery. Three hundred and thirty elective isolated coronary artery bypass graft surgery patients are included. Patients with previous arrhythmia and hyperthyroidism are excluded. Patient characteristics including age, gender, EF, functional class and LA size are checked. In case group (165 patients) 24 hours prior to surgery 2 grams of vitamin C (IV) is given and in next 48 hours in ICU and 48 hours of ward 500 mg per day is given. The control group are given placebo. Two groups are compared for atrial fibrillation occurrence by monitoring in ICU and 3 times a day checking ECG in the ward. Incidence of atrial fibrillation in compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090228945N2
Registration date:2017-05-05, 1396/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-05, 1396/02/15
Registrant information
Name
Amir Mirmohammadsadeghi
Name of organization / entity
Isfahan Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3260 0961
Email address
am_sadeghi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
hospital and researcher
Expected recruitment start date
2016-12-05, 1395/09/15
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive use of ascorbic acid for postoperative atrial fibrillation in patients undergoing coronary artery bypass graft surgery
Public title
Preventive use of ascorbic acid for postoperative atrial fibrillation
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion:
no arrhythmia, coronary artery bypass alone, normal sinus rhythm preoperatively
exclusion criteria:
emergency operation, antiarryhthmic drug postoperatively
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
330
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of the University of Medical Sciences
Street address
Isfahan University of Medical Science
City
Isfahan
Postal code
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.MUI.REC.1395.4.049
Health conditions studied
1
Description of health condition studied
cardiac arrhythmia
ICD-10 code
197.8
ICD-10 code description
Other postprocedural disorders of circulatory system, not elsewhere classified
Primary outcomes
1
Description
atrial fibrillation
Timepoint
3 days in ICU then in ward
Method of measurement
ECG
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 165 patients receive vitamin C
Category
Treatment - Drugs
2
Description
Control group: 165 patients receive placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Sina Hospital
Full name of responsible person
Dr Amir Mirmohammad Sadeghi
Street address
Isfahan Sina Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University, Najafabad branch
Full name of responsible person
Vice chancellor for Research
Street address
Islamic Azad University, Najafabad branch, Najafabad, Isfahan, Iran
City
Najafabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Islamic Azad University, Najafabad branch
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
Islamic Azad University, Najafabad branch
Full name of responsible person
Amir Mirmohammad Sadeghi
Position
Cardiac Surgeon
Other areas of specialty/work
Street address
Isfahan Sina Hospital
City
Isfahan
Postal code
Phone
+98 913 108 5664
Fax
Email
am_sadeghi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Najafabad branch
Full name of responsible person
Amir Mirmohammad Sadeghi
Position
Cardiac surgen
Other areas of specialty/work
Street address
Isfahan Sina hospital
City
Isfahan
Postal code
Phone
+98 913 108 5664
Fax
Email
am_sadeghi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Najafabad branch
Full name of responsible person
Amir Mirmohammad Sadeghi
Position
Cardiac Surgeon
Other areas of specialty/work
Street address
Isfahan Sina Hospital
City
Isfahan
Postal code
Phone
+98 913 108 5664
Fax
Email
am-sadeghi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)