Protocol summary

Summary
This cross-sectional study in non-random sampling that was done in the Emergency Department of Imam Reza hospital of Mashhad University of Medical Sciences from the July 2015 to March 2016 for a period of 9 months, on 50 CPR patients due to cardiac arrest. Aim of this study is to investigate the effect of epinephrine in combination with prednisolone compared with epinephrine alone on neurological complications in patients with cardiopulmonary arrest, accordingly, for a group epinephrine will be used in combination with methylprednisolone and for the else will be used alone. Patients who are expired before taken to hospital and patients who have just suffered a respiratory arrest without cardiac arrest will be excluded. Information collected on the Utstein-style which includes items such as patient demographic characteristics (such as age, gender), etiology and clinical picture presentation and cardiopulmonary arrest, time and date, location, interventions and actions before and after cardiac arrest, interval interventions, and establish circulation (ROSC) return of spontaneous circulation and CPR final outcome. The neurological outcomes for all patients considered to be revived by CPC Scure in the first 24 hours and one week later.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015060822623N1
Registration date: 2015-08-15, 1394/05/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-15, 1394/05/24
Registrant information
Name
esmat seyedi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 6657
Email address
seyedie921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Siences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of epinephrine in combination with prednisolone on neurological complications in patients with cardiopulmonary arrest
Public title
Efficacy of epinephrine in combination with prednisolone compared with epinephrine alone in patients with cardiopulmonary arrest
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients with cardiopulmonary arrest that CPR done for them Exclusion criteria: patients that was died before receive to hospital; patient with just pulmonary arrest without heart arrest; in patient that infusion was not possible
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Mashhad University of Medical Siences
Street address
Ethics Committee, Ghoreishi building, Daneshgah ave
City
mashhad
Postal code
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
930178

Health conditions studied

1

Description of health condition studied
Cardiopulmonary arrest
ICD-10 code
I26, I27,
ICD-10 code description
Pulmonary heart disease and diseases of pulmonary circulation

Primary outcomes

1

Description
CPR outcome
Timepoint
After the Cardiopulmonary recession
Method of measurement
Survive or expire

Secondary outcomes

1

Description
Neurological complications
Timepoint
24 hour and one week after CPR
Method of measurement
By CPC scure

Intervention groups

1

Description
We administer epinephrine in combination with 40 mgr intravenous prednisolone for the first group of patients with cardiopulmonary arrest
Category
Treatment - Drugs

2

Description
We administer just epinephrine in second group of patients.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
dr. Esmat Seyedi
Street address
dr.Shariaati Spuare
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vice chancellor of research, Dr. Mohsen Tafaghodi
Street address
Daneshgah ave, Ghoreishi building, vice chancellor of research
City
mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Esmat Seyedi
Position
MD, Resident of Emergency Medicine
Other areas of specialty/work
Street address
Department of Emergency Medicine, Emam Reza Hospital
City
Mashhad
Postal code
Phone
+98 518525312
Fax
Email
seyedie921@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Emergency Medicine, Mashhad University of Medical Siences
Full name of responsible person
Dr.Ehsan Bolvardi
Position
Emergency medicine specialist, assistant professor of emergency medicine
Other areas of specialty/work
Street address
Department of emergency medicine, Emam Reza hospital
City
Mashhad
Postal code
Phone
+98 518467185
Fax
Email
Bolvardie@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Esmat seyedi
Position
MD, Resident of Emergency Medicine
Other areas of specialty/work
Street address
Department of emergency medicine, Emam Reza hospital
City
Mashhad
Postal code
Phone
+98 518525312
Fax
Email
seyedie921@mums.ac.ir
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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