Comparison of the Effectiveness of Central versus Peripheral Administration of Epinephrine in Success of Return of Spontaneous Circulation in Cardiopulmonary Arrest Patients
The aim of this study is to compare central versus peripheral administration of Epinephrine during cardiopulmonary resuscitation
Design
This study is a two arm parallel groups clinical trial with double blinding. sample size is estimated based on the census subjects in each group.
Settings and conduct
This study setting is at Namazi Hospital, Shiraz. Trained PGY-2 and PGY-3 emergency medicine residents will be the leader of CPR. Outcome assessors are blinded to treatment allocation. The one who record the data is blinded to the type of interventions and the investigators doing the analysis are not the same as those administering drug and performing the procedures.
Participants/Inclusion and exclusion criteria
Inclusion criteria include adult patients with cardiopulmonary arrest admitted to the emergency department of Namazi hospital. Exclusion criteria include patients with age less than 18 years old, all patients with GCS = 3 before CPR, and all patients expired before CPR.
Intervention groups
The patients will be allocated into two study groups. Patients in the group one will be administered 1 mg Epinephrine every 3-5 minutes through peripheral venous during CPR, while the patients in the group two will be received 1 mg Epinephrine every 3-5 minutes administering through central venous. All the patients will have central or peripheral line before resuscitation
Main outcome variables
The primary outcomes are the systolic and diastolic blood pressure and heart rate after return of spontaneous circulation, and elapsed time to return of spontaneous circulation. In addition, we will be considered success rate and mortality rate as secondary outcomes.
General information
Reason for update
Acronym
CPR (cardiopulmonary resuscitation)
IRCT registration information
IRCT registration number:IRCT20180613040087N2
Registration date:2020-02-22, 1398/12/03
Registration timing:retrospective
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Azadeh Tafakori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3822 9856
Email address
tafakori@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Central versus Peripheral Administration of Epinephrine in Success of Return of Spontaneous Circulation in Cardiopulmonary Arrest Patients
Public title
Epinephrine administration during cardiopulmonary resuscitation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients with cardiopulmonary arrest admitted to the emergency department of Namazi hospital
Exclusion criteria:
Patients with age less than 18 years old
All patients with GCS = 3 before CPR
All patients expired before CPR
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
8
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessors are blinded to treatment allocation. The one who record the data is blinded to the type of interventions and the investigators doing the analysis are not the same as those administering drug and performing the procedures.
Placebo
Not used
Assignment
Parallel
Other design features
All patients will be immediately resuscitated based on AHA guidelines. All patients will have central or peripheral line before resuscitation. Trained PGY-2 and PGY-3 emergency medicine residents will be the leader of CPR. Sample size is estimated based on the census subjects in each group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz Univesity of Medical Sciences
Street address
Headquarters of Shiraz Univesity of Medical Sciences, Zand St, Shiraz
City
Shiraz
Province
Fars
Postal code
1456946111
Approval date
2019-02-19, 1397/11/30
Ethics committee reference number
IR.SUMS.MED.REC.1397.537
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
Systolic and diastolic blood pressure
Timepoint
After return of spontaneous circulation
Method of measurement
Sphygmomonometer
2
Description
Heart rate
Timepoint
After return of spontaneous circulation
Method of measurement
Chronometer
3
Description
Elapsed time to return of spontaneous circulation
Timepoint
After return of spontaneous circulation
Method of measurement
Chronometer
Secondary outcomes
1
Description
Success rate of return of spontaneous circulation
Timepoint
After return of spontaneous circulation
Method of measurement
Monitor and pulse checking
2
Description
Mortality rate
Timepoint
After return of spontaneous circulation
Method of measurement
Monitor and pulse checking
Intervention groups
1
Description
Control group: Patients in the group one will be administered 1 mg Epinephrine every 3-5 minutes through peripheral venous during CPR. All the patients will have peripheral line before resuscitation.
Category
Treatment - Drugs
2
Description
Intervention group:The patients in the group two will be received 1 mg Epinephrine every 3-5 minutes administering through central venous. All the patients will have central line before resuscitation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Azadeh Tafakori
Street address
Namazi square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 6474 3322
Email
nemazee_inf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Merzad Lotfi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Babak Bagheri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department, Namazi hospital, Zand Ave
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4952
Email
babakbagheri86@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Tafakori
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department, Namazi hospital, Zand Ave
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4952
Email
dr.azadeh.tafakori@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Tafakori
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department, Namazi hospital, Zand Ave
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4952
Email
dr.azadeh.tafakori@gmail.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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data related to the patients will be shared after identifying the patients
When the data will become available and for how long
Starting 1 month after publication
To whom data/document is available
This only available for people working in academic institutions
Under which criteria data/document could be used
All statistical analysis are allowed in line with the objectives of the study. Application terms for access to data including: People working in academic institutions who have registered a protocol liked our study. People are committed to data protection