NCT00125229

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury
• Intracranial Hypertension

Interventions

Type	Name	Description
DRUG	Mannitol
DRUG	Hypertonic Saline

Timeline

• Start date: 2005-08-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2005-07-29
• Last updated: 2012-06-26

Locations

1 site across 1 country: United States