The present study was conducted to evaluate magnesium sulfate therapeutic efficacy and safety in patients with a severe diffuse axonal injury . 38 Traumatic patients diagnosed with severe and moderate diffuse axonal injury at the age of 18 to 65 years old who were admitted within 1 hour after trauma enrolled in our study.All patients randomly assigned to 1 of 2 treatment groups. group A: the patients were given an initial loading dose of 50 mg/kg magnesium sulfate and then 50 mg/kg every 6 hours up to 24 hours after the trauma and group B: given normal saline as a plasebo.The initial treatment consisted of ventilation, antibiotic prophylaxis with cefotaxime or ceftriaxone, seizure prophylaxis with phenytoin, gastric ulcer prophylaxis with ranitidine and urinary catheterization were done in all patents. Finally all patients were evaluated within 2 month with respect to clinical regression, GCS and motor function scores to evaluate efficacy of magnesium sulfate in the patients with diffuse axonal injury.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111158098N2
Registration date:2012-01-11, 1390/10/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-11, 1390/10/21
Registrant information
Name
Yazdan Dokht Gafari Momeneh
Name of organization / entity
faculty of medicine, tabriz medical university
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4667
Email address
shohadahospita@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research,Faculty of Medicine.Tabriz University of Medical Science
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2011-02-04, 1389/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Magnesium Sulfate on the Clinical Course and GCS of Patients with Severe Diffuse Axonal Injury
Public title
Effect of Magnesium Sulfate on Diffuse Axonal Injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Older than 18 and less than 65 years old; the time gap between trauma and admission to the medical center not exceeding more than one hour
Exclusion criteria: renal failure; pregnancy; seizure; cardiac heart failure;cranial hematoma; intracranial surgery for hematoma; refractory systemic hemorrhage requiring blood product transfusion; intracranial hemorrhage
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
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
Deputy for Research,Faculty of Medicine,Tabriz University of Medical Science
Street address
Deputy for Research,Faculty of Medicine, Golgasht Ave. Tabriz.IR.IRAN
City
Tabriz
Postal code
Approval date
2010-08-03, 1389/05/12
Ethics committee reference number
543488
Health conditions studied
1
Description of health condition studied
brain trauma
ICD-10 code
S06.2
ICD-10 code description
Diffuse brain injury
Primary outcomes
1
Description
Glascow coma scale (GCS)
Timepoint
with in 2 month after trauma
Method of measurement
According to GCS score table
2
Description
motot function
Timepoint
2 month after trauma
Method of measurement
according to evaluating muscle force
Secondary outcomes
1
Description
adverse effect of magnesium sulfate
Timepoint
within 24 hours after magnesium sulfate administration
Method of measurement
yes or no
Intervention groups
1
Description
initial intravenous loading dose of 50mg/kg magnesium sulfate within one hour after trauma and then 50mg/kg every 6 hour magnesium sulfate up to 24 hours after trauma
Category
Treatment - Drugs
2
Description
intravenous normal saline with the same dose of drug intervention
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Research,Faculty of Medicine.Tabriz University of Medical Science
Full name of responsible person
DR. A. Meshkini
Street address
Deputy for Research,Faculty of Medicine, Golgasht Ave. Tabriz.IR.IRAN
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research,Faculty of Medicine.Tabriz University of Medical Science
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
Tabriz University of Medical Science
Full name of responsible person
Yazdan Dokhte Gafari M
Position
Medical Student
Other areas of specialty/work
Street address
Tabriz University of Medical science, Faculty of Medicine
City
Tabriz
Postal code
Phone
+98 41 1336 4667
Fax
Email
y.dokhtegafary@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emam Reza Hospital
Full name of responsible person
M.Shakeri
Position
Assistant Professor
Other areas of specialty/work
Street address
Emam Reza Hospital, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1336 4667
Fax
Email
mshakeri@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Emam Reza Hospital
Full name of responsible person
M.Shakeri
Position
Assistant Professor
Other areas of specialty/work
Street address
Emam Reza Hospital, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1336 4667
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)