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Effect of hypertonic saline 5% on elevated intracranial pressure in traumatic brain injury

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201011055107N1
Enrollment
60
Registered
2011-03-30
Start date
2010-03-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury. S06.1,S06.2,S06.3,S06.4,S06.5,S06.6,S06.7,S06.8,S06.9

Interventions

Intervention 1: 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. Intervention 2: 125 cc HSS 5% as bolus for 1 hour Q 6 hr for 3 days. Interv
Treatment - Drugs
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
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

Sponsors

Tehran University of Medical Science and Health Services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age 18 - 65 years, closed traumatic brain injury, GSC score 3-12, hemodianamically stable (CVP 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
S100B. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: blood sampling and ELISA kit.;Reactive oxygen species. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: blood sampling and ELISA kit.;Total antioxidant power. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: blood sampling and ELISA kit.

Secondary

MeasureTime frame
APACHE II score. Timepoint: baseline and every 6 hours for 4 days. Method of measurement: international table.;SOFA score. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: international table.;Glasgow Coma Scale. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: international table.;Heart rate. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: mmhg.;Respiratory rate. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: monitoring device in ICU.;Pottasium. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: laboratory.;Serum creatinine. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: laboratory.;Temperature. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: thermometer.;Central vein pressure. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: central vein pressure ruler.;Mean arterial pressure. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: (SPB+2DBP)/3.;Platelet count. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: laboratory.;Hemoglobin. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: laboratory.;White blood cell (WBC) count. Timepoint: baseline and after 1, 2, 3 days. Method of measurement: laboratory.;Serum sodium. Timepoint: baseline and every 6 hour for 4 days. Method of measurement: laboratory.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Narjes Hendoiee

Department of clinical pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences and Heal

hendoui@razi.tums.ac.ir hendoieen@yahoo.com+98 21 6695 4709

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026