Stroke is the leading cause of death and leading cause of disability in adult. The purpose of this clinical trial is Evaluation of the intravenous Magnesium sulfate effect in clinically improvement of patient with acute ischemic stroke. Patients will be randomly selected in neurology emergency of Farabi & Emam Reza hospital of Kermanshah. A group of 97 patients who clinically diagnosed acute ischemic stroke will be enrolled. The patients will be randomly allocated into one of two groups.we will administer Magnesium sulfate 4gr IV in 50 cc normal saline over 15 minutes followed by 16 gr in 100cc over 24 hoursas a continuous infusion. The placebo group received equal volumes of normal saline alone .In all patients measure of global disability according to modified Rankin scale and NIH stroke scale will be assessed before of the treatment, 3days after treatment and discharge time .finally, measure of global disability, amount of admition times and mortality rate in each group will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901101856N2
Registration date:2010-03-30, 1389/01/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-03-30, 1389/01/10
Registrant information
Name
Dariush Afshari
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1835 0177
Email address
dafshari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
Expected recruitment start date
2010-03-11, 1388/12/20
Expected recruitment end date
2010-12-11, 1389/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the intravenous Magnesium sulfate effect in clinically improvement of patient with acute ischemic stroke
Public title
Evaluation of the Magnesium sulfate effect in ischemic stroke treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient’s age between 40-95 years,last known well time within 12 hoursof treatment initiation . Exclusion criteria:pregnancy-coma -heart block-chronic renal impairment- respiratory distress(24 < RR < 12 یا o2sat < 90)- systolic blood pressure <90 or >220mmhg- pre-existing neuralgic psychiatric or advanced systemic disease that confound neuralgical or functional outcome evaluation -hemorrhagic stroke - known recent stroke wheithin past 30 days- rapidly resolving deficit
Age
From 40 years old to 95 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
97
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences and Health Servises Ethical Comitte
Street address
Shahid Beheshti boulevard, Kermanshah
City
Kermanshah
Postal code
Approval date
empty
Ethics committee reference number
88113
Health conditions studied
1
Description of health condition studied
ischemic stroke
ICD-10 code
I64
ICD-10 code description
Stroke
Primary outcomes
1
Description
measure of global disability
Timepoint
before of the treatment ,3days after treatment and discharge time
Method of measurement
according to modified Rankin scale
2
Description
mortality rate
Timepoint
During admition times
Method of measurement
patient' s medical documents
3
Description
amount of admition times
Timepoint
discharge time
Method of measurement
patient' s medical documents
Secondary outcomes
1
Description
Clinical side effects
Timepoint
daily
Method of measurement
According to patients daily notes
Intervention groups
1
Description
Magnesium sulfate 4gr IV in 50 cc normal saline over 15 minutes followed by 16 gr in 100cc over 24 hours
Category
Treatment - Drugs
2
Description
equal volumes of normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital of Kermanshah
Full name of responsible person
Dr Dariush Afshari
Street address
Ashayer boulevard, Dolat Abad, Kermanshah
City
Kermanshah
2
Recruitment center
Name of recruitment center
Emam Reza Hospitl of Kermanshah
Full name of responsible person
dr nasrin moradian
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr Farid Najafi
Street address
Shahid Beheshti boulevard, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
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
Emam Reza hospital
Full name of responsible person
Dr Dariush Afshari
Position
Neurologist/assistant professor/chairman
Other areas of specialty/work
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
dafshari@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emam Reza hospital
Full name of responsible person
Dr Dariush Afshari
Position
Neurologist/assistant professor/chairman
Other areas of specialty/work
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
dafshari@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Emam Reza Hospitl
Full name of responsible person
dr nasrin moradian
Position
Resident of neurology
Other areas of specialty/work
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)