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Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients

Terminated
Conditions
Traumatic Brain Injury
Intracranial Hypertension
Registration Number
NCT00125229
Lead Sponsor
The University of Texas Health Science Center at San Antonio
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 intracranial hypertension following serious traumatic brain injury (TBI).

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 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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
10
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU)

🇺🇸

San Antonio, Texas, United States

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