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Evaluation of the efficacy of intravenous administration of magnesium and pottasium solution in cardioversion of postoperative atrial fibrillation: a randomized, double blind, placebo-controlled trial

Protocol summary

Study aim
Evaluation of the efficacy of intravenous administration of magnesium and pottasium solution in cardioversion of postoperative atrial fibrillation
Design
Phase III, Randomized, Double blind, Placebo-Controlled trial, with a parallel group design of 360 patients. Randomization was done with permuted random block
Settings and conduct
The study performs on post operative atrial fibrillation patients who underwent isolated coronary artery bypass graft surgery, in Tehran Heart Center.After random assignment to groups A and B, patients are treated according to the study protocol. If atrial fibrillation persists after 6 hours, both groups would be treated with Amiodarone protocol. The blind group includes the patient, the data collector, the researcher, and the outcome assessor
Participants/Inclusion and exclusion criteria
The inclusion criteria are: atrial fibrillation occurrence after isolated coronary artery bypass graft surgery that ontinued for at least 15 minutes after initiation, serum Potassium level of 4 - 4.5 and serum Magnesium level of 2 - 3.5 meq/L, and having the informed consent to participate in the study The exclusion criteria are: unstable hemodynamic, history of atrial fibrillation before surgery, serum creatinine level more than 1.4 mg/dl, patients receiving packed cell or Inotrope, Hemoglobin level less than 7 g/L, spontaneous cardioversion before randomization
Intervention groups
Intervention group (A): administration of a Metohexal tablet 47.5 mg and Potassium/Magnesium solution. If atrial fibrillation persists after 6 hours, Amiodarone infusion would be initiated control group (B): administration of a Metohexal tablet 47.5 mg and placebo. If atrial fibrillation persists after 6 hours, Amiodarone infusion would be initiated
Main outcome variables
Cardioversion of post operative atrial fibrillation after isolated coronary artery bypass graft surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180430039488N2
Registration date: 2020-05-03, 1399/02/14
Registration timing: registered_while_recruiting

Last update: 2020-05-03, 1399/02/14
Update count: 0
Registration date
2020-05-03, 1399/02/14
Registrant information
Name
Farzad Masoudkabir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
fmasoudkabir@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of intravenous administration of magnesium and pottasium solution in cardioversion of postoperative atrial fibrillation: a randomized, double blind, placebo-controlled trial
Public title
Efficacy of intravenous administration of magnesium and pottasium solution in cardioversion of postoperative atrial fibrillation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Atrial fibrillation after isolated coronary artery bypass graft surgery Continuation of atrial fibrillation rhythm for at least 15 minutes after initiation Serum Potassium level of 4-4.5 meq/L Serum Magnesium level of 4-4.5 meq/L Informed consent to participate in the study
Exclusion criteria:
Unstable hemodynamic (systolic blood pressure less than 90 mmHg) History of atrial fibrillation (persistent or paroxysmal) before surgery Serum creatinine level more than 1.4 mg/dl More than 12 hours have passed since the beginning of the atrial fibrillation rhythm Patients receiving packed cell Hemoglobin level less than 7 g/L Spontaneous cardioversion before randomization Patients receiving Inotrope
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 360
Randomization (investigator's opinion)
Randomized
Randomization description
permuted block randomization containing 4 subjects in each block eg : AABB. A refers to intervention group and B refers to controls.
Blinding (investigator's opinion)
Double blinded
Blinding description
After randomization and assignment of patients to group A or B, the appropriate solution for each group is prepared and infused by the nurse according to the protocol, but the patient,the person collecting the data, the researcher and the evaluator of the outcome will be unaware of the patient's treatment group as well as the type of solution that the patient has received. Collected data of the study will be entered in the SPSS and then analysed by an independent expert from Tehran heart center research institute.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Jala-Al-ahmad highway, North Kargar street
City
Tehran
Province
Tehran
Postal code
3135674193
Approval date
2019-07-21, 1398/04/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.343

Health conditions studied

1

Description of health condition studied
Postoperative atrial fibrillation
ICD-10 code
I97.89
ICD-10 code description
Other postprocedural complications and disorders of the circulatory system, not elsewhere classified

Primary outcomes

1

Description
Cardioversion of atrial fibrillation to sinus rhythm within the first 6 hour
Timepoint
From the start of the intervention until 6 hours later
Method of measurement
Cardiac rhythm monitoring

Secondary outcomes

1

Description
Time required to convert atrial fibrillation rhythm to sinus rhythm (in the first 6 hours)
Timepoint
From the start of the intervention until 6 hours later
Method of measurement
Cardiac rhythm monitoring

2

Description
Heart rate less than 110 beats per minute during the first 3 hours of treatment
Timepoint
From the start of the intervention until 3 hours later
Method of measurement
Cardiac rhythm monitoring

3

Description
The rate of recurrence of atrial fibrillation in the first 48 hours after the restoration of sinus rhythm
Timepoint
From the time of sinus rhythm restoration to 48 hours later
Method of measurement
Cardiac rhythm monitoring

4

Description
The rate of sinus rhythm restoration within 24 hours of Amiodarone initiation
Timepoint
From the initiation of Amiodarone infusion to 24 hours later
Method of measurement
Cardiac rhythm monitoring

5

Description
The cumulative dose of Amiodarone required to restore sinus rhythm
Timepoint
From the initiation of Amiodarone infusion to restoration of sinus rhythm
Method of measurement
The total amount of Amiodarone that is prescribed until restoration of sinus rhythm

6

Description
The time required to restore the sinus rhythm after initiation of Amiodarone infusion
Timepoint
From the initiation of Amiodarone infusion to restoration of sinus rhythm
Method of measurement
Total sum of time, in minutes, from the initiation of Amiodarone infusion to restoration of sinus rhythm

7

Description
The rate of bradycardia (heart rate less than 60/minute) in the first 6 hours after starting intervention
Timepoint
From the start of the intervention until 6 hours later
Method of measurement
Cardiac rhythm monitoring

8

Description
The rate of systolic blood pressure less than 90 mm Hg in the first 6 hours after starting intervention
Timepoint
From the start of the intervention until 6 hours later
Method of measurement
Blood pressure monitoring

Intervention groups

1

Description
Intervention group: administration of a Metoprolol succin tablet 47.5 mg (Metohexal) and Potassium/Magnesium solution (10 cc of 15% potassium chloride solution of Shahid Ghazi company and 4 cc of 50% magnesium sulfate solution of Shahid Ghazi company diluted in 250 cc of half saline serum, infused over 60 minutes). If the sinus rhythm does not restore after 6 hours, Amiodarone infusion (150 mg Amiodarone of Alborz Daru company within 10 minutes, then 1 mg per minute for 6 hours, and then 0.5 mg per minute for 18 hours) would be initiated. After Amiodarone infusion, the patient is treated with 200 mg Amiodarone tablets every 12 hours. If restoration of sinus rhythm occurs within the first 6 hours, Amiodarone will not be prescribed.
Category
Treatment - Drugs

2

Description
Intervention group: administration of a Metoprolol succin tablet 47.5 mg (Metohexal) and placebo ( 250 cc of half saline serum, infused over 60 minutes). If the sinus rhythm does not restore after 6 hours, Amiodarone infusion (150 mg Amiodarone of Alborz Daru company within 10 minutes, then 1 mg per minute for 6 hours, and then 0.5 mg per minute for 18 hours) would be initiated. After Amiodarone infusion, the patient is treated with 200 mg Amiodarone tablets every 12 hours. If restoration of sinus rhythm occurs within the first 6 hours, Amiodarone will not be prescribed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Farzad Masoudkabir
Street address
Jala-Al-ahmad highway, North Kargar street
City
Tehran
Province
Tehran
Postal code
3135674193
Phone
+98 21 8802 9600
Email
fmasoudkabir@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhundzadeh, MD
Street address
Jala-Al-ahmad highway, North Kargar street
City
Tehran
Province
Tehran
Postal code
3135674193
Phone
+98 21 8802 9600
Email
fmasoudkabir@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Farzad Masoudkabir
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Jala-AL ahmad high way, North Kargar street
City
Tehran
Province
Tehran
Postal code
3135674193
Phone
+98 21 8802 9600
Email
Fmasoudkabir@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohre Mohammadi
Position
Cardilogy resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Jala-AL ahmad highway, North Kargar street
City
Tehran
Province
Tehran
Postal code
3135674193
Phone
+98 21 8802 9600
Email
zohrem28@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohre Mohammadi
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Jala-AL ahmad highway, North Kargar street
City
Tehran
Province
Tehran
Postal code
3135674193
Phone
+98 21 8802 9600
Email
zohrem28@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Particular parts of the data will be released
When the data will become available and for how long
After release of the results
To whom data/document is available
Scientific institutions
Under which criteria data/document could be used
Further analysis
From where data/document is obtainable
Zohre Mohammadi ,MD
What processes are involved for a request to access data/document
Formal or official request by an institution
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