Effect of 0.5, 1, 1.5 g / kg doses of monnitol 20% in reduction of brain edema and increase in post-traumatic consciousness level in patients with diffuse axonal injury accompanied with edema and brain midline shifting more than 5 mm
This study compared the effects of different doses of 0.5, 1, 1.5 g / kg of mannitol 20% inreducing brain edema and increasing alertness in post-traumatic patients with the diagnosis of diffuse axonal injury accompanied by edema and brain shifting of more than 5 mm. Patients with diffuse axonal injury aged 15 to 60 years old, level of consciousness less than 8, brain edema, brian shifting from midline greater than 5 mm and no history of renal failure or severe electrolyte imbalances.
Variables of 30 patients treated by doses of 0.5, 1 and 1.5 g/kgwere measured every 6 hours for 48 hours and brain edema, shifting from midline and level of consciousness in patients were evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040312888N1
Registration date:2013-06-20, 1392/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-20, 1392/03/30
Registrant information
Name
Mohammad Asghari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 0830
Email address
asgharim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Science
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2013-03-15, 1391/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 0.5, 1, 1.5 g / kg doses of monnitol 20% in reduction of brain edema and increase in post-traumatic consciousness level in patients with diffuse axonal injury accompanied with edema and brain midline shifting more than 5 mm
Public title
The effect of mannitol in reducing brain edema and increasing the level of consciousness in patients with brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
(Inclusion criteria: age 15 to 60 years, patients with diffuse axonal injury: level of consciousness of less than 8; edema and brian shifting from midline of more than 5 mm; willingness to participate in the study. Exclusion criteria: renal failure, intense electrolyte imbalance; death throughout the study)
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputyof Faculty Medicine
Street address
Research Department, 3rd floor of 2nd central bulding of Tabriz university of Medical Sciences, Daneshghah Ave.
City
Tabriz
Postal code
3357310112
Approval date
2011-05-01, 1390/02/11
Ethics committee reference number
91200
Health conditions studied
1
Description of health condition studied
Diffuse brain injury
ICD-10 code
s06.2
ICD-10 code description
Diffuse brain injury
Primary outcomes
1
Description
Brain edema severity
Timepoint
On admission and 48 hours after admission
Method of measurement
Brain edema will be meseaured by CT scan on admission and 48 hours after admission and the findings will be graded based on the cistern basal being open, semi-open and close from1-3.
Secondary outcomes
1
Description
Brain midline shift
Timepoint
On admission and 48 hours after admission
Method of measurement
Brain edema will be meseaured by CT scan on admission and 48 hours after admission and will be calculated based on the midline shifting formula.(middle shift=biparietal diametr-2SP)
2
Description
level of consciousness
Timepoint
On admission and 48 hours after admission
Method of measurement
The GCS Glasgow Coma Scale score of 3 to 15 have been measured to be between
Intervention groups
1
Description
mannitol 20% 0.5 mg/kg WB
Category
Treatment - Drugs
2
Description
Mannitol%20 1g/kg WB
Category
Treatment - Drugs
3
Description
mannitol%20 1.5g/kg WB
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Educational and Training Hospital
Full name of responsible person
Hadi Ebrahimi
Street address
Emam Reza Hospital, Golgasht St
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Asgari Mohammad
Street address
Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Asghari Mohammad
Position
MD-Neurosurgeon
Other areas of specialty/work
Street address
Emam Reza Educational and Training Hospital
City
Tabriz
Postal code
Phone
+98 41 1334 0830
Fax
+98 41 1334 0830
Email
ebrahimihadi@yahoo.com
Web page address
imamreza.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical
Full name of responsible person
Ebrahimi Hadi
Position
MD
Other areas of specialty/work
Street address
Emam Reza Educational and Training Hospital
City
Tabriz
Postal code
Phone
+98 41 1545 3263
Fax
+98 41 1334 0830
Email
ebrahimihadi@yahoo.com
Web page address
Imamreza.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)