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Comparison between Vasopressin and Epinephrine in neurologic survival in prehospital patient with cardiopulmonary arrest by serum level of s100b

Protocol summary

Summary
The current study aims to investigate the efficiency and comparison of vasopressin and epinephrine in individual’s, selected as randomized clinical trial, referring to pre-hospital emergencies in Tehran. However, for evaluation the neurological status of patients, their sera were subjected to be examined by S100B after CPR. In one hand, the inclusion criteria will be the cardiopulmonary arrest, lack of carotid pulse, age above 18 years, and non-traumatic. On the other hand, the exclusion criteria will be the history of steroids use, pregnancy, and death at the entrance to the hospital. For each group, 50 samples will be collected from patients with arrest out of the hospital. According to the America Heart Association 2010 guidelines, vasopressin or epinephrine will be administered randomly. Then, the S100B in sera will be evaluated after 24 hours.

General information

Acronym
CPR.OHCA
IRCT registration information
IRCT registration number: IRCT2014060717891N2
Registration date: 2015-02-08, 1393/11/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-08, 1393/11/19
Registrant information
Name
Nader Tavakoli
Name of organization / entity
Iran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8891 5410
Email address
tavakoli.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-06-20, 1393/03/30
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Vasopressin and Epinephrine in neurologic survival in prehospital patient with cardiopulmonary arrest by serum level of s100b
Public title
Comparison between Vasopressin and Epinephrine in Cardiopulmonary Resuscitation
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion:.cardiopulmonary arrest; no carotid pulse;age>18 ;nontreumatic exclusion:corticosteroid therapy;pregnancy ;death in hospital
Age
From 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
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
Iran University of Medical Sciences
Street address
Tehran.Hemmat highway
City
Tehran
Postal code
Approval date
2014-04-29, 1393/02/09
Ethics committee reference number
93د/494/105

Health conditions studied

1

Description of health condition studied
Cardiopulmonary arrest
ICD-10 code
I46.0
ICD-10 code description
Cardiac arrest with successful resuscitation

Primary outcomes

1

Description
Neurologic outcome post cpr
Timepoint
24 hour post cpr
Method of measurement
s100b neuropeptid

Secondary outcomes

1

Description
Roc percentage
Timepoint
18 Month
Method of measurement
Observational

Intervention groups

1

Description
Intervention group: Vasopressin, 40 unit, Instead first or second dose of Epinephrin, Intravenous, sampling for S100B checking 24 hour later
Category
Treatment - Drugs

2

Description
Control group : Epinephrine 1mg, from start CPR, every 3_5 minutes , Intravenous , Sampling for S100B checking 24 hour later
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Prehospital Emergency
Full name of responsible person
Dr.Haghi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Exir Company
Full name of responsible person
DR.Mostafavi
Street address
Tehran, Behambari Alley, Zartosht Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Exir Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Ghafourian
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Tehran.Satarkhan,Hazrat Rasoul Hospital
City
Tehran
Postal code
Phone
+98 21 4446 3965
Fax
Email
nasim.gh.91@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Ghafourian
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Teharan, Satarkhan, Hazrat Rasoul Hospital
City
Tehran
Postal code
Phone
+98 21 4446 3965
Fax
Email
dr_negar2006@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Ghafourian
Position
Resident
Other areas of specialty/work
Street address
Tehran, Satarkhan, Hazrat Rasoul Hospital
City
Tehran
Postal code
Phone
+98 21 4446 3965
Fax
Email
nasim.gh.91@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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