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

Stopped early

Conditions studied: Traumatic Brain Injury, Intracranial Hypertension

In brief

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).

Key facts

Study ID

NCT00125229

Run by

The University of Texas Health Science Center at San Antonio

People needed

10

Starts

2005-08-01

Expected to finish

2006-06-01

Last updated by the study team

2012-06-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU) — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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