Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
This is a clinical study comparing the physiologic effects of two hypertonic solutions (mannitol, hypertonic saline) with a particular emphasis on changes in cerebral blood flow in patients with intracranial hypertension following serious traumatic brain injury (TBI).
Traumatic Brain Injury
Drug: Hypertonic Saline
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients|
|Study Start Date:||August 2005|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
This is a study comparing effects of two hypertonic solutions (mannitol, 6.4% hypertonic saline) on intracranial hypertension, cerebral blood flow, serum/urine osmolarity in patients with increased intracranial pressure caused by traumatic brain injury. The study is conducted during first 72 hours after the injury without any interference with standard medical treatment as performed at the institution. When the hypertonic solution is indicated by caregiver, the study team is informed and performs a set of physiologic bedside measurements including evaluation of cerebral blood flow and changes in plasma and urine osmolarity. The study is noninvasive and the study protocol does not hamper, in any way, standard care of treatment for these patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125229
|United States, Texas|
|Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU)|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Roman Hlatky, M.D.||Center for Neurosurgical Sciences - UTHSC San Antonio|