Protocol summary

Study aim
This study was a randomized, double blind clinical trial. 400 patients with open heart surgery candidates were randomly divided into two groups, with and without (control) amiodarone. Finally, the prevalence of cardiac arrhythmias after surgery until the patient's stay in the intensive care unit is recorded in the questionnaires.
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 501 patients, enrolled between April 2016 and March 2018, and followed for one year
Settings and conduct
In the intervention group, 200 mg of amiodarone was given orally twice a day until the patient was cleared. Patients in the control group received placebo (vitamin B1). The frequency and duration of use of placebo in the control group were completely similar to the oral administration of amiodarone in the intervention group. Electrocardiogram monitoring was conducted continuously and monitored.
Participants/Inclusion and exclusion criteria
Age over 18 years, [pen heart surgery, Sinus rhythm and normal function of liver, renal system , pulmonary system and thyroid. History of atrial and ventricular arrhythmia and cardiac blocks, patient's need for Pace, anti-arrhythmic therapy, Age over 80 years, pregnant patients
Intervention groups
In the intervention group, 200 mg of amiodarone was given orally twice a day until the patient was cleared. Patients in the control group received placebo (vitamin B1). The frequency and duration of use of placebo in the control group were completely similar to the oral administration of amiodarone in the intervention group.
Main outcome variables
Incidence of types of arrhythmia, duration of admission to ICU, hospitalization time and side effects of amiodarone

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151109024975N8
Registration date: 2018-07-07, 1397/04/16
Registration timing: retrospective

Last update: 2018-07-07, 1397/04/16
Update count: 0
Registration date
2018-07-07, 1397/04/16
Registrant information
Name
Gohar Eslami
Name of organization / entity
Mazandaran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3695
Email address
g.eslami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Scienses
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
empty
Scientific title
Efficacy of Oral Amiodarone Administration on Prevention of Cardiac Arrhythmia Following Open Heart Surgery, aRandomized Clinical trial Study
Public title
Efficacy of Oral Amiodarone in atrial fibrillation after open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Candidate for open heart surgery Preoperative sinus rhythm Normal function of liver, renal system , pulmonary system and thyroid
Exclusion criteria:
History of atrial and ventricular arrhythmia and cardiac blocks with any degree before surgery Patient's need for Pace Anti-arrhythmic therapy before surgery The history of thyroid and lung and renal disease and hepatitis Age over 80 years Pregnant patients Allergy to Amiodarone
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 400
Actual sample size reached: 400
Randomization (investigator's opinion)
Randomized
Randomization description
Random method and description of each method: simple randomization After determining the size of the sample, 400 people, 200 in the control group and 200 in the intervention group were considered. By co-ordinating medical records, this number was considered average for the duration of the appointment, and then the list of individuals was determined. The list was prepared based on the patients' turn-by-turn and then, using the random numbers table, the numbers of the control and intervention group were determined and compared to the coordination for the next steps.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and therapists are not aware of the type of drug present in the pills (amiodarone or vitamin B1), and only the researcher knows about the code inserted (code A or code B) on the pill pack.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Research Deputy of Mazandaran University of Medical Sciencesm Moalem Square
City
Sari
Province
Mazandaran
Postal code
48175-861
Approval date
2017-04-09, 1396/01/20
Ethics committee reference number
IR.MAZUMS.REC.95.2146

Health conditions studied

1

Description of health condition studied
Arrhythmia after open heart surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Prevention of various types of arrhythmias after open heart surgery
Timepoint
Duration of hospitalization
Method of measurement
monitoring

Secondary outcomes

1

Description
Duration of admission to ICU
Timepoint
Duration of hospitalization
Method of measurement
Monitoring and file

2

Description
Duration of hospitalization
Timepoint
Duration of hospitalization
Method of measurement
Monitoring and file

3

Description
Side effects of amiodarone
Timepoint
Duration of hospitalization
Method of measurement
Monitoring and file

Intervention groups

1

Description
Control group: Patients in the control group received placebo (vitamin B1). The frequency and duration of placebo in the control group were similar to the oral administration of amiodarone tablets in the intervention group (twice a day and up to discharge). Patients undergoing coronary artery bypass grafting, the drug is fed through the nasopharyngeal tube. The placebo is structurally similar to the amiodarone tablet, which is used in this study with a 300mg of vitamin B1 tablet that looks similar to the 200mg tablet in terms of its appearance.
Category
Placebo

2

Description
Intervention group: 200 mg of amiodarone is given orally twice a day until the patient's discharge. . Patients who underwent coronary artery bypass grafting were injected through the nasopharyngeal tube. . Electrocardiogram monitoring was conducted continuously and monitored and educated nurses monitored the monitor frequently, and if any irregularities in rhythm were observed, they identified the type of arrhythmia of the patients and recorded the questionnaires. Eventually, the prevalence of cardiac arrhythmias and other items in the questionnaire was recorded in the questionnaires up to one week after the open heart surgery in the patients.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh-zahra hospital Mazandaran University of Medical Scienses
Full name of responsible person
Gohar Eslami
Street address
َArtesh Blvd - Center of the heart of Mazandaran
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3331 4086
Fax
+98 11 3332 4002
Email
g.eslami@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Moalem Square, Research Deputy of MazandaranUniversity of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3326 1244
Email
g.eslami@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3354 3695
Fax
+98 11 3354 3695
Email
g.eslami@mazums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3354 3695
Fax
+98 11 3335 2725
Email
g.eslami@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3354 3695
Fax
+98 11 3335 2725
Email
g.eslami@mazums.ac.ir
Web page address

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
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