Status:
TERMINATED
Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Traumatic Brain Injury
Intracranial Hypertension
Eligibility:
All Genders
18-70 years
Brief Summary
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 intra...
Detailed Description
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 in...
Eligibility Criteria
Inclusion
- Patients with severe TBI (motor Glasgow Coma Scale \[GCS\] score \< 5)
- Age \> 18 years
- Health care provider indicated a treatment of intracranial hypertension using hyperosmotic agent
Exclusion
- Brain dead (GCS 3, fixed dilated pupils)
- Life-threatening systemic injuries (AIS \> 4 in an organ system other than brain); AIS = Abbreviated Injury Score
- Hypotension not responsive to fluid resuscitation and low doses of dopamine
- Clinical or imaging sign/suspicion for internal carotid artery injury
Key Trial Info
Start Date :
August 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00125229
Start Date
August 1 2005
End Date
June 1 2006
Last Update
June 26 2012
Active Locations (1)
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1
Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU)
San Antonio, Texas, United States, 78229