Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125229
Status:
TERMINATED
Last Update Posted:
2012-06-26
First Post:
2005-07-27
Brief Title:
Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Dr Hladky died Sept 2006 prior to study completion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 64 hypertonic saline on intracranial hypertension cerebral blood flow serumurine 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None