In this study, the effect of simvastatin on the outcome of patients with brain injuries will be evaluated. In a randomized, double-blind study, 42 patients with brain injuries will be randomly assigned to one of the following two groups: Group 1 (Control) will receive the placebo, and Group 2 (S) will be administered 80 mg of simvastatin at the first day which followed by 40 mg up until the patients are admitted in ICU. The level of CRP and IL6 will be measured on the first day and 72 hours after the injury. The following data will be recorded by a blinded observer:
The number of the Days at which the patients are admitted in ICU, the admission GCS, the discharge GCS, the Date of connecting and disconnecting the patient from the ventilator, the Date of Start and stop of the vasoactive utilage and finally, the patients mortality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305075363N3
Registration date:2013-09-21, 1392/06/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-21, 1392/06/30
Registrant information
Name
Taraneh Naghibi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 2865
Email address
tnaghibi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2013-05-01, 1392/02/11
Expected recruitment end date
2014-05-01, 1393/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the simvastatin effect on the outcome of patients with brain injuries in ICU
Public title
Assessment of the simvastatin effect on the outcome of patients with brain injuries in ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: APACHEE score less than 35, age between 18 and 60 years old, patients with brain injuries that scheduled to ICU admission
Exclusion criteria:Receiving NSAIDS or corticosteroids, known hypersensitivity to the study drugs, history of cardiac, respiratory, neuromuscular, hepatic or renal diseases, history of brain injuries and pregnancy.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
42
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
Zanjan University of Medical Sciences
Street address
Azadi Blvd.Vice- Chancellor for Research of Zanjan University of Medical Sciences, Zanjan, Iran