Comparison of the effect of amiodarone and osmolol on heart rate control
Comparison of the effect of amiodarone and osmolol on the need for vasopressor
Comparison of the effect of amiodarone and osmolol on the need for fluid therapy
Design
Patients based on clinical and hemodynamic conditions in the presence of sepsis shock Receiving norepinephrine(NEP) for more than 24 hours with a mean blood pressure(MAP) above 65 mm Hg despite appropriate fluid therapy and heart rate above 95 . The sample size of each group in this study is 15 patients.
Settings and conduct
This study is a clinical trial study performed in the intensive care unit of Sinai Hospital.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Patients over 18 years; Suffering from sepsis shock requires receiving vasopressor; Heart rate above 100 beats per minute; Gaining informed consent; Cardiac index above 2.5; Absence of arrhythmia
Exclusion criteria:
Previous treatment with beta-blocker or amiodarone in the last 48 hours; Patient with valvular problems; Pregnancy; Pulmonary fibrosis; Retinoid; Known pulmonary pressure; valvular disorder; Aortic aneurysm; CPR post conditions; ARDS
Intervention groups
Patients are divided into two groups. In the first group, amiodarone and in the second group, esmolol is started as a heart rate control drug.
Main outcome variables
Medium arterial pressure; stroke volume index; Cardiac output index; heart rate; systemic Vascular resistance; fluid requirement; Vasopressor need
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190929044923N1
Registration date:2021-01-16, 1399/10/27
Registration timing:retrospective
Last update:2021-01-16, 1399/10/27
Update count:0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
masoud khataminia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4446 7101
Email address
masoodkhataminia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effects of Heart Rate Control with Amiodarone and esmolol on Hemodynamic and Clinical Outcomes in Patients with Septic Shock
Public title
A Comparison of the effects of amiodarone and osmolol in patients with septic shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
septic shock receiving vasopressor despite adequate fluid therapy
Heart rate above 100 beats per minute for no apparent reason (such as fever, agitation, pain, anemia, and hypovolemia that should be treated before starting medication and hemodynamic tests)
Cardiac index above 2.5 liters / minute per square meter
Absence of arrhythmia
Exclusion criteria:
treatment with beta-blocker or amiodarone in the last 48 hours
Patient with heart valve problems
Pregnancy
Pulmonary fibrosis
Hypo / Hyperthyroidism
Known pulmonary hypertension
History of amiodarone intolerance
Post CPR conditions
Aortic aneurysm
ARDS with PaO2 / FiO2 less than 150
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Vice Chancellor for Research and Technology, Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology
City
tehran
Province
Tehran
Postal code
1996835113
Approval date
2019-07-23, 1398/05/01
Ethics committee reference number
IR.TUMS.VCR.REC.1398.426
Health conditions studied
1
Description of health condition studied
septic shock
ICD-10 code
A41.9
ICD-10 code description
Sepsis, unspecified organism
Primary outcomes
1
Description
stroke volume index
Timepoint
0,6,12,24 hour after adminstration
Method of measurement
uscom
2
Description
cardiac output index
Timepoint
0 612 24 hours after adminstration
Method of measurement
uscom
3
Description
heart rate
Timepoint
0 6 12 24 hours after adminstration
Method of measurement
heart rate monitoring device
4
Description
vascular resistance
Timepoint
0, 6 12 24 after adminstration
Method of measurement
uscom
5
Description
acid lactic
Timepoint
baseline and 24hours after administration
Method of measurement
laboratory analysis
6
Description
mean arterial pressure
Timepoint
0, 6 12 24 after adminstration
Method of measurement
monitoring device
7
Description
Vasopressor intake rate
Timepoint
0, 6 12 24 after adminstration
Method of measurement
View Cardex
8
Description
The amount of fluid received
Timepoint
baseline and 24hours after administration
Method of measurement
View Cardex
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention included amiodarone group therapy: After measuring the patient's hemodynamic characteristics, cardiac output, vascular resistance by uscom, patients are treated with amiodarone. The dose of amiodarone in these patients according to Guidalin is 150 ACC / AHA mg for 10 minutes and then infusion of 1-0.5 mg / minute. The dosage of this drug is adjusted so that patients are divided into the following groups based on heart rate. - If the heart rate is more than 100 beats per minute, continuous infusion of 1 mg / minute is started. - If the heart rate is more than 90 beats and less than 100 beats per minute, continuous infusion of 0.5 mg / min is started. If the target heart rate is not reached, it is increased by 1 mg / min every 20 minutes. If it is more than 70 times and less than 80 times per minute, the infusion is reduced to 0.5 mg per minute. - If the heart rate is more than 60 times and less than 70 times per minute, the infusion is 1 mg / minute.
Category
Treatment - Drugs
2
Description
Control group: esmolol treatment control group: In this group, after measuring the patient's hemodynamic characteristics, cardiac output, vascular resistance by uscom device, patients are treated with esmolol. The goal is a heart rate of 85 beats per minute. The esmolal dose of the infusion in these patients is 20 μg / kg / min. The dosage of this drug is adjusted in such a way that patients are divided into the following groups based on heart rate. - If the heart rate is more than 100 beats per minute, it starts with 20 μg / kg / min. - If the heart rate Start between 100-90 times per minute esmolol starts at a dose of 10 μg / kg / min. - If the target heart rate is not reached, it will increase by 20 micrograms / kg every 20 minutes. If the heart rate is between 80-70 beats per minute, the infusion is reduced to 10 μg / kg / min. If the heart rate is between 70-60 beats per minute, the infusion is reduced to 20 μg / kg / min. If the following is observed, the infusion of esmolol is stopped: - If the heart rate drops below 60: The infusion is stopped for 20 minutes and then continues with an increase in heart rate above 70 beats per minute at half the previous speed . ScvO2 ≤ 60% OR LV ejection fraction ≤ 25% OR Cardiac Index ≤ 2.0 L / min / m2 - In case of bronchospasm, the drug is permanently discontinued and It does not start again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ُSina hospital
Full name of responsible person
masoud khataminia
Street address
sina hospital, emam khomeini street , hassan abad
City
tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 4446 7101
Email
masoodkhataminia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mojtaba mojtahedzadeh
Street address
sina hospital,emam khomeini street, hassan abad
City
tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8500
Email
masoodkhataminia@yahoo.com
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
masood khataminia
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
sina hospital emem khomeini street , hasan abad
City
tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8500
Email
masoodkhataminia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
masoud khataminia
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
sina hospital , emam khomeini street, hassan abad
City
tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
021ر66348500
Email
masoodkhataminia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
masoud khataminia
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
sina hospital , emam khomeini astreet , hassan abad
City
tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8500
Email
masoodkhataminia@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
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
Title and more details about the data/document
The raw data obtained from this study, an an excel or SPSS file will be provided to them at the request of the project supervisor or the reviewer of the article
When the data will become available and for how long
After writing the initial draft of the article
To whom data/document is available
project supervisor or the reviewer of the article upon their request
Under which criteria data/document could be used
If re-analyis of the data is needed
From where data/document is obtainable
Written correspondence with the first executor of the project
What processes are involved for a request to access data/document
Written correspondence with the first executor of the project if necessary to re-analyze the data