Determination of the prophylactic role of magnesium tablets on reduction of atrial fibrillation rhythm in patients undergone coronary artery bypass graft surgery
Design
A randomized clinical trial, phase 3 with parallel groups, that includes a control group, design of 70 patients.
Settings and conduct
This study will be done at Heshmat Hospital in Rasht on patients undergoing Coronary artery bypass graft surgery. Seventy patients randomly and with quadruple block method will be divided in two groups of magnesium sulfate and control. Magnesium level of plasma will be controlled daily for both groups And if it was higher than normal, the medication will be discontinued for the intervention group. Patients who have arterial fibrillation(AF) rhythm in the monitor for more than 30 seconds are considered as AF+ patients. Finally, the data will be compared in 2 groups.This study does not require blindness and patients and the surgeon are aware of the process.
Participants/Inclusion and exclusion criteria
InclusionCriteria: Only cardiopulmonary bypass graft surgery (not associated with valve operation).First-time open heart surgery.Ejection Fraction(EF) more than 35%.
Non-inclusion Criteria: History of Previous arterial fibrillation(AF), History of kidney disease, History of showing an allergic reaction to magnesium, History of taking antiarrhythmic drugs.
Intervention groups
Intervention group: A 250 milligrams magnesium tablet (produced by the 21st-century company) will be prescribed daily from 48 hours before the operation.After the operation and transferred to ICU, if the patient is extubated, orally and if still intubated, through NGT tube, he will receive next doses till the fifth-day after the operation.
The control group won't receive any drug.
Main outcome variables
Arterial fibrillation rhythm in patients undergoing Cardiopulmonary bypass graft surgery, Hospitalization time in ICU and hospital
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190413043252N1
Registration date:2019-05-18, 1398/02/28
Registration timing:prospective
Last update:2019-05-18, 1398/02/28
Update count:0
Registration date
2019-05-18, 1398/02/28
Registrant information
Name
gholamreza kanani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 9066
Email address
dr_kanani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sulfate magnesium tablet on atrial fibrillation after coronary artery bypass grafting in Heshmat Hospital in 2019
Public title
The effect of sulfate magnesium on atrial fibrillation after open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Only cardiopulmonary bypass graft surgery (not associated with valve operation).
First-time open heart surgery
Ejection Fraction(EF) more than 35%
Exclusion criteria:
History of Previous arterial fibrillation(AF)
History of kidney disease
History of taking magnesium and showing an allergic reaction
History of taking antiarrhythmic drugs (such as amiodarone -digoxin -warfarin)
Being pregnant
Having a pacemaker
AV BLOCK In the ECG
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected based on inclusion criteria and then classified into two groups receiving magnesium sulfate and control group, using the random block method in quadruple blocks based on the obtained list. To generate random sequences in this clinical trial, http://www.graphpad.com/quickcalcs/index.cfm will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Guilan University Of Medical Sciences
Street address
Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.GUMS.REC.1397.493
Health conditions studied
1
Description of health condition studied
Atrial fibrillation and fluttery
ICD-10 code
شماره 148
ICD-10 code description
IX 100-199 Diseases of the circulatory system
Primary outcomes
1
Description
Effect on prevention of AF rhythm in patients with coronary artery bypass graft surgery
Timepoint
24-hour patient monitoring until the fifth day
Method of measurement
ECG monitoring
Secondary outcomes
1
Description
Reducing hospitalization time in the ICU and hospital, and thus reducing patient hospitalization costs
Timepoint
After patient's discharge from hospital
Method of measurement
Number of hospitalization days
Intervention groups
1
Description
Intervention group: All pre-operative patients will be interviewed and the method will be explained to them and written informed consent will be obtained. In both groups, a blood sample for magnesium serum will be taken first and if it is within the normal range (1/5-2/5 milliequivalents per liter), from 48 hours pre-operation, a 250 milligrams magnesium tablet (manufacturer: 21st century)will be given to intervention group at 6 am. This step is done by a collaborator nurse. After surgery and transfer to the ICU, both groups of patients undergo intensive care and ECG monitoring. The intervention group, in case of staying intubated they will take the tablet through NGT tube and if extubated they will take it orally their next 6 am tablet and it will be continued till the fifth day after surgery. The nurse giving the drug to the patient is not in the care team. Magnesium level of plasma in both groups will be controlled daily and if it was higher than the normal range, the medication will be stopped. All this time, a collaborator anesthetist is aware of receiving the drug by intervention group and will intervene immediately in the event of a complication.
Category
Prevention
2
Description
Control group: This group does not receive any drug.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat Hospital
Full name of responsible person
Dr Gholamreza Kanani
Street address
Heshmat Hospital, at the beginning of bayani street, Mosalla Square
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 1666 9064
Email
heshmat@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Doctor Shadman Nemati
Street address
Vice Chancellor for research of Guilan,Shahid Siadati Avenue, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
drshadmannemati_ent@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Gholamreza Kanani
Position
Assistant Professor of Cardiology
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Heshmat Hospital,at the beginning of bayani street,Mosalla Square
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3366 9066
Fax
Email
dr_kanani@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Gholamreza Kanani
Position
Assistant Professor of Cardiology
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Heshmat Hospital,at the beginning of bayani street,Mosalla Square
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3366 9066
Fax
Email
dr_kanani@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohadese Ahmadi
Position
Research Expert/(MSc) English
Latest degree
Master
Other areas of specialty/work
Research Expert
Street address
Anestesiology Reseaech Center, Alzahra Hospital, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9328
Email
p.ahmadi2311@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available