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

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ClinicalTrials.gov Identifier: NCT00125229
Recruitment Status : Terminated (Dr. Hladky died Sept 2006 prior to study completion)
First Posted : July 29, 2005
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Intracranial Hypertension Drug: Mannitol Drug: Hypertonic Saline Phase 4

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.

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
Study Start Date : August 2005
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125229


Locations
United States, Texas
Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Roman Hlatky, M.D. Center for Neurosurgical Sciences - UTHSC San Antonio

Publications:

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00125229     History of Changes
Other Study ID Numbers: 045-1503-266
First Posted: July 29, 2005    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012

Keywords provided by The University of Texas Health Science Center at San Antonio:
Hypertonic Saline
Mannitol
Intracranial hypertension
Cerebral blood flow
Traumatic brain injury

Additional relevant MeSH terms:
Hypertension
Brain Injuries
Brain Injuries, Traumatic
Intracranial Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs