Comparison of prophylactic effect versus therapeutic effect of amiodarone in patients undergoing heart surgery at risk of atrial fibrillation: a double-blind randomized clinical trial
To assess the prophylactic effect versus therapeutic effect of amiodarone in patients undergoing heart surgery at risk of atrial fibrillation
Design
This is a double-blind randomized clinical trial, phase II, in which 200 eligible patients will be randomly assigned to the intervention and control groups.
Settings and conduct
The eligible patients undergoing heart surgery referring to the Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 18 to 65 years old; candidate for elective cardiac surgery; having a preoperative sinus rhythm.
Exclusion criteria: use of antihypertensive drugs other than beta-blockers or ACE inhibitors; thyroid, renal, pulmonary, hepatic disorders; asthma; bradycardia; heart failure; atrioventricular block; sensitivity to amiodarone.
Intervention groups
Intervention group: intravenous infusion of amiodarone (manufactured by Shahr Daroo Pharmaceutical Co.) 350 mg 24 hours before surgery.
Control group: intravenous infusion of amiodarone (manufactured by Shahr Daroo Pharmaceutical Co.) 350 mg 24 hours after surgery.
Main outcome variables
Primary outcome: incidence of atrial fibrillation.
Secondary outcome: incidence of side effects (such as hypotension and bradycardia).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N392
Registration date:2021-05-02, 1400/02/12
Registration timing:prospective
Last update:2021-05-02, 1400/02/12
Update count:0
Registration date
2021-05-02, 1400/02/12
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylactic effect versus therapeutic effect of amiodarone in patients undergoing heart surgery at risk of atrial fibrillation: a double-blind randomized clinical trial
Public title
Comparison of prophylactic effect versus therapeutic effect of amiodarone in patients undergoing heart surgery at risk of atrial fibrillation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18 to 65 years old
Candidate for elective cardiac surgery
Having a preoperative sinus rhythm
Exclusion criteria:
Use of antihypertensive drugs other than beta-blockers or ACE inhibitors
Thyroid, renal, pulmonary, hepatic disorders
Asthma
Bradycardia
Heart failure
Atrioventricular block
Sensitivity to amiodarone
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-04-10, 1400/01/21
Ethics committee reference number
IR.UMSHA.REC.1400.071
Health conditions studied
1
Description of health condition studied
Atrial fibrillation
ICD-10 code
I48.91
ICD-10 code description
Unspecified atrial fibrillation
Primary outcomes
1
Description
Incidence of atrial fibrillation
Timepoint
24 hours after surgery
Method of measurement
Using a monitor machine
Secondary outcomes
1
Description
Incidence of side effects (such as hypotension and bradycardia)
Timepoint
24 hours after surgery
Method of measurement
using a monitor machine
Intervention groups
1
Description
Intervention group: Intravenous infusion of amiodarone (manufactured by Shahr Daroo Pharmaceutical Co.) 350 mg 24 hours before surgery
Category
Treatment - Drugs
2
Description
Control group: Intravenous infusion of amiodarone (manufactured by Shahr Daroo Pharmaceutical Co.) 350 mg 24 hours after surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital in Hamadan city
Full name of responsible person
Dr Mehran Jabari Mehrabani
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
School of Medicine,
Phone
+98 81 3838 0572
Email
mehran_jabbari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mehran Jabari Mehrabani
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mehran_jabbari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Reza Salim Bahrami
Position
Anesthesiologist
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
salimbahramidr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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