1. Home
  2. Approved trials
  3. » فارسی

Comparison of prophylactic and therapeutic effect of amiodarone in heart surgery patients at risk of atrial fibrillation

Protocol summary

Study aim
Comparison of prophylactic and therapeutic effect of amiodarone in heart surgery patients prone to atrial fibrillation
Design
Clinical trial with control group, parallel groups, randomized, 200 patients, randomization by card
Settings and conduct
This study will be performed as a clinical trial on cardiac patients who are candidates for elective surgery. The research will be conducted in Farshchian Educational and Medical Center of Hamedan in 1400. In the intervention group, patients received an intravenous infusion of 350 mg amiodarone 24 hours before surgery. In the postoperative control group, amiodarone is injected three minutes before the removal of the aortic clamp, and within 30 minutes to 24 hours after admission to the ICU, patients are cared for and possible cardiac arrhythmias are recorded.
Participants/Inclusion and exclusion criteria
inclusion criteria: En Candidate patients for elective cardiac surgery ASA class 2 & 3 Consent to participate in the study Having a sinus rhythm before surgery No history of amiodarone allergy exclusion criteria: En Recipients of antihypertensive drugs except beta blockers and ACE inhibitors Patients with thyroid, renal, pulmonary, hepatic disorders Asthmatics Rate of less than 50 Heart failure Atrioventricular block
Intervention groups
In the intervention group, patients will receive an intravenous infusion of 350 mg amiodarone 24 hours before surgery. In the postoperative amiodarone control group, it is injected three minutes before the aortic clamp is removed, and within 30 minutes to 24 hours after admission to the ICU, patients are cared for and in case of cardiac arrhythmias is recorded. if arrhythmia is observed, the patient will be continuously monitored with EKG.
Main outcome variables
Atrial fibrillation: supraventricular tachyarrhythmia with uncoordinated atrial activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210424051058N1
Registration date: 2021-05-27, 1400/03/06
Registration timing: prospective

Last update: 2021-05-27, 1400/03/06
Update count: 0
Registration date
2021-05-27, 1400/03/06
Registrant information
Name
mehran jabari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3111 1300
Email address
mehran_jabbari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylactic and therapeutic effect of amiodarone in heart surgery patients at risk of atrial fibrillation
Public title
The effect of Amiodarone in heart surgery patients prone to atrial fibrillation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for elective cardiac surgery ASA class 2 & 3 Consent to participate in the study Having a sinus rhythm before surgery No history of amiodarone allergy
Exclusion criteria:
Recipients of antihypertensive drugs except beta blockers and ACE inhibitors Patients with thyroid, renal, pulmonary, hepatic disorders Asthmatics Rate of less than 50 Heart failure Atrioventricular block
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be randomly assigned to the prevention and Intervention group. For this purpose, 50 cards are prepared and written on 25 letters C means prevention and on the other 25 letters I means the Intervention group and each of them is placed in an envelope with aluminum foil and their lids are glued inside. We put a box. When patients arrive, we randomly remove one of the envelopes and open the lid. According to the selected letter (C or I) inside it, we assign the patient to the prevention and Intervention group. With the selection of each patient, the card is set aside so that all the cards are selected. Then return all the cards to the box and repeat this process four times to reach the desired sample size.
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 Hamadan University of Medical Sciences
Street address
Ethics Committee in Research, Office of Vice Chancellor for Education, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
65176-19657
Approval date
2021-04-09, 1400/01/20
Ethics committee reference number
IR.UMSHA.REC.1400.071

Health conditions studied

1

Description of health condition studied
atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter

Primary outcomes

1

Description
Atrial fibrillation: It means uncoordinated atrial activity and consequent mechanical atrial insufficiency.
Timepoint
The outcome of the intervention will be reviewed and compared before the intervention and one week after the intervention.
Method of measurement
ECG

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, patients will receive 350 mg of amiodarone as an intravenous infusion 24 hours before surgery. Within 30 minutes to 24 hours after admission to the ICU, patients are cared for and in the event of cardiac arrhythmias such as premature ventricular fibrillation; Premature atrial fibrillation; Branch blocks; Asystole; VT; VF ..... is recorded and also cardiac arrhythmias and interventions performed according to the opinion of the surgeon or anesthesiologist
Category
Treatment - Drugs

2

Description
Control group: In the control group, amiodarone is injected after surgery and three minutes before removal of the aortic clamp. EKG is taken in case of arrhythmic symptoms (such as palpitations, tachycardia, hypotension, shortness of breath, etc.) and if arrhythmia is observed, the patient will be monitored continuously with EKG.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Mehran Jabari
Street address
Farshchian hospital, fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
65176-19657
Phone
+98 81 3265 0020
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.saeed bashirian
Street address
Office of Vice Chancellor for Education, International Affairs Directory Hamedan University of Medical Sciences (UMSHA), Building No. 4, fahmideh blv., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
65176-19657
Phone
+98 81 3253 3254
Email
s_bashirian@yahoo.com
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
Mehran Jabbari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Besat hospital, Shahid Motahary Blv, Hamadan
City
Hamadan
Province
Hamadan
Postal code
65176-19657
Phone
+98 918 811 2759
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
Mehran Jabbari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Besat hospital, Shahid Motahary Blv, Hamadan
City
Hamadan
Province
Hamadan
Postal code
65176-19657
Phone
+98 918 811 2759
Email
mehran_jabbari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehran Jabbari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Besat hospital, Shahid Motahary Blv, Hamadan
City
Hamadan
Province
Hamadan
Postal code
65176-19657
Phone
+98 918 811 2759
Email
mehran_jabbari@yahoo.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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
Information about the variables studied in this research will be shared.
When the data will become available and for how long
After publishing the relevant article
To whom data/document is available
researchers
Under which criteria data/document could be used
The information that the researchers are looking for should not be exactly the same as the findings of the published article in this study. Apart from the mentioned cases, other analyzes and extraction of information considered by the researchers from the data are unimpeded. The study data will also be provided to researchers without the identity information of the study participants
From where data/document is obtainable
mehran_jabbari@yahoo.com
What processes are involved for a request to access data/document
The researcher must first email the following account and submit his request: mehran_jabbari@yahoo.com If the researcher's request is approved, the data will be emailed to him / her within a maximum of one month.
Comments
Loading...