Comparison of the effect of epinephrine in combination with methylprednisolone on neurological complications and the need for vasopressor after resuscitation in patients with cardiopulmonary arrest
Comparison of the effect of epinephrine in combination with methylprednisolone on neurological complications and the need for vasopressor after resuscitation in patients with cardiopulmonary arrest
Design
This study is double-blinded clinical trial.The study population will be included all patients suffering from cardiac arrest refer to emergency department of Imam Reza hospital of Kermanshah.342 eligible patients will be selected conveniently and randomly will be assigned to intervention and control groups.
Settings and conduct
This study, which will be conducted at Imam Reza hospital of Kermanshah, is double-blinded one. Participants and researchers will be unaware and keep blinded to the allocation of study groups. Methyl prednisolone and normal saline will be prepared in similar syringes, and the injector only performs the injection according to the specific code.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Above 18 years old ;No previous neurological disorders
Exclusion criteria:Patients who do not have the possibility of injections during recovery due to the lack of peripheral blood vessels; Patients with respiratory cardiac arrest outside the hospital
Intervention groups
The intervention group, in addition to receiving one mg of epinephrine, in each respiratory resuscitation cycle will receive 125 mg intravenous methylprednisolone every 3 to 5 minutes later.
The control group, in addition to receiving one mg of epinephrine, in each respiratory resuscitation cycle, every 3 to 5 minutes later will received 125 mg intravenous normal saline as placebo .
Main outcome variables
Neurological complications; Hypertension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N127
Registration date:2019-07-27, 1398/05/05
Registration timing:registered_while_recruiting
Last update:2019-07-27, 1398/05/05
Update count:0
Registration date
2019-07-27, 1398/05/05
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-15, 1398/02/25
Expected recruitment end date
2019-08-16, 1398/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of epinephrine in combination with methylprednisolone on neurological complications and the need for vasopressor after resuscitation in patients with cardiopulmonary arrest
Public title
Comparison of the effect of epinephrine in combination with methylprednisolone on neurological complications in patients with cardiopulmonary arrest
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Above 18 years old
No previous neurological disorders
Cardiopulmonary arrest
Exclusion criteria:
Patients who do not have the possibility of injections during recovery due to the lack of peripheral blood vessels
Patients with cardiopulmonary arrest outside the hospital
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
342
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants and researchers are unaware and will be keep blinded to the allocation of study groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-04-24, 1398/02/04
Ethics committee reference number
ir.kums.rec.1398.107
Health conditions studied
1
Description of health condition studied
Cardiopulmonary arrest
ICD-10 code
I46
ICD-10 code description
Cardiac arrest
Primary outcomes
1
Description
Neurological complications
Timepoint
24 hours after resuscitation
Method of measurement
Based on a doctor's Checking out and according to Cerebral performance category.
2
Description
hypertension
Timepoint
24 hours after resuscitation
Method of measurement
Using Digital Blood Pressure
3
Description
Rhythm during resuscitation
Timepoint
24 hours after resuscitation
Method of measurement
Using a heart rhythm monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group, in addition to receiving one mg of epinephrine, in each respiratory resuscitation cycle, every 3 to 5 minutes later will received125 mg intravenous methylprednisolone .
Category
Treatment - Drugs
2
Description
The intervention group, in addition to receiving one mg of epinephrine, in each respiratory resuscitation cycle, every 3 to 5 minutes later will received 125 mg intravenous normal saline as placebo .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Nasrin Bahrami
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Rejimdarmani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice chancellor for research of Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin Bahrami
Position
Resident of Emergency Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Emam Reza Hospital, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6330
Email
Rejimdarmani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hooman Rafee Surori
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6330
Email
Hooman_rafiee@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin Bahrami
Position
Resident of Emergency Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Emam Reza Hospital, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 34276330
Email
Rejimdarmani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Sharing scientific data is available to researchers
From where data/document is obtainable
To receive the documentation, email send for update manager
Email: Rejimdarmani@yahoo.com
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail