Refractory intracranial hypertension is a leading cause of death in head injured children who reach the hospital alive. There is increasing evidence that hypertonic saline can reduce intracranial pressure (ICP) sufficiently if used as upfront therapy to avoid uncontrollable intracranial hypertension. A well-established relationship between adequate control of the ICP and outcome, methods to improve ICP control are still urgently needed. A pilot prospective randomized trial of standard therapy recommended by the American Association of Neurolological Surgeons, adjusted for children, and standard therapy plus hypertonic saline is proposed. 40 children will be randomized into the 2 groups. The primary outcome measure will be percent time that the ICP is greater than 20. Secondary outcome measures of efficacy will include the frequency of objective neuroworsening as defined by Morris et al., the 6-month Glasgow Outcome Scale, the COAT (Children's Orientation Amnesia Test), and the Divided Attention Test.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21HD041240-01
Application #
6400953
Study Section
Special Emphasis Panel (ZHD1-DSR-L (24))
Program Officer
Ansel, Beth
Project Start
2001-09-21
Project End
2003-06-30
Budget Start
2001-09-21
Budget End
2002-06-30
Support Year
1
Fiscal Year
2001
Total Cost
$183,540
Indirect Cost
Name
University of California San Diego
Department
Surgery
Type
Schools of Medicine
DUNS #
077758407
City
La Jolla
State
CA
Country
United States
Zip Code
92093