Comparative Evaluation of the Effects of Hypertonic Saline 5% Infusion vs Bolus on Traumatic Brain Biomarker S100B and Oxidative Stress Total antioxidant power (TAP), ROS (Reactive Oxygen Species) in Traumatic Brain Injury
This study evaluates efficacy and safety of osmotic agents, mannitol as the first line agent for years Vs hypertonic saline solution 5% (HSS5%) (Bolus Vs infusion) in the treatment of high intracranial pressure (ICP) In adult Traumatic Brain Injury (TBI) with GCS = 3-12. In this study, 30 adult TBI with GCS = 3-12 are randomly assigned three groups to receive 125 cc HSS 5% as bolus for 1 hour Q 6 hr for 3 days, 500 cc HSS 5% as infusion Q 24 hr for 3 days, or manitol 20% as a bolus of 1 g/kg, repeated doses can be given at 0.25 to 0.5 g/kg every six hours as needed. Serum S100B, ROS, TAP HSS5% hemodynamic and coagulation profiles, serum sodium and potassium, and osmolarity levels will be evaluated at the baseline, and daily for 3 days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011055107N1
Registration date:2011-03-30, 1390/01/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-03-30, 1390/01/10
Registrant information
Name
Narjes Hendoiee
Name of organization / entity
Department of clinical pharmacy, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
hendoui@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of the Effects of Hypertonic Saline 5% Infusion vs Bolus on Traumatic Brain Biomarker S100B and Oxidative Stress Total antioxidant power (TAP), ROS (Reactive Oxygen Species) in Traumatic Brain Injury
Public title
Effect of hypertonic saline 5% on elevated intracranial pressure in traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 - 65 years, closed traumatic brain injury, GSC score 3-12, hemodianamically stable (CVP<15 and MAP <65 mmhg), serum Na: 135- 140meq/l, serum creatinin < 1.5 or urine output > 0.5 cc/hr, at least one reactive pupil, INR less than 1.5, Serum osmolality ≤ 320 mOsm/kg
Exclusion Criteria: pregnancy, Penetrating trauma, spinal cord injury, Serum Na> 160meq/l or less than 135meq/l, Scr>1.5 mg/dl, ARF during the treatment
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:
60
Randomization (investigator's opinion)
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
Tehran University of Medical Sciences and Health Services