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

Sponsored by:	The University of Texas Health Science Center at San Antonio
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00125229

Purpose

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	Intervention	Phase
Traumatic Brain Injury Intracranial Hypertension	Drug: Mannitol Drug: Hypertonic Saline	Phase IV

MedlinePlus related topics: High Blood Pressure Traumatic Brain Injury

Drug Information available for: Mannitol

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Estimated Enrollment:	10
Study Start Date:	August 2005
Estimated Study Completion Date:	June 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125229

Contacts

Contact: Roman Hlatky, M.D.

210-567-5625

hlatky@uthscsa.edu

Locations

United States, Texas
Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU)	Recruiting
San Antonio, Texas, United States, 78229
Contact: Roman Hlatky, M.D. 210-567-5625 hlatky@uthscsa.edu
Principal Investigator: Roman Hlatky, M.D.

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

More Information

Publications:

Miller JD, Becker DP, Ward JD, Sullivan HG, Adams WE, Rosner MJ. Significance of intracranial hypertension in severe head injury. J Neurosurg. 1977 Oct;47(4):503-16.

Doyle JA, Davis DP, Hoyt DB. The use of hypertonic saline in the treatment of traumatic brain injury. J Trauma. 2001 Feb;50(2):367-83. Review. No abstract available.

Wade CE, Kramer GC, Grady JJ, Fabian TC, Younes RN. Efficacy of hypertonic 7.5% saline and 6% dextran-70 in treating trauma: a meta-analysis of controlled clinical studies. Surgery. 1997 Sep;122(3):609-16.

Valadka AB, Robertson CS. Should we be using hypertonic saline to treat intracranial hypertension? Crit Care Med. 2000 Apr;28(4):1245-6. Review. No abstract available.

Berger S, Schurer L, Hartl R, Deisbock T, Dautermann C, Murr R, Messmer K, Baethmann A. 7.2% NaCl/10% dextran 60 versus 20% mannitol for treatment of intracranial hypertension. Acta Neurochir Suppl (Wien). 1994;60:494-8.

Worthley LI, Cooper DJ, Jones N. Treatment of resistant intracranial hypertension with hypertonic saline. Report of two cases. J Neurosurg. 1988 Mar;68(3):478-81.

Qureshi AI, Suarez JI, Bhardwaj A, Mirski M, Schnitzer MS, Hanley DF, Ulatowski JA. Use of hypertonic (3%) saline/acetate infusion in the treatment of cerebral edema: Effect on intracranial pressure and lateral displacement of the brain. Crit Care Med. 1998 Mar;26(3):440-6.

Qureshi AI, Wilson DA, Traystman RJ. Treatment of elevated intracranial pressure in experimental intracerebral hemorrhage: comparison between mannitol and hypertonic saline. Neurosurgery. 1999 May;44(5):1055-63; discussion 1063-4.

Vialet R, Albanese J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7.

Battison C, Andrews PJ, Graham C, Petty T. Randomized, controlled trial on the effect of a 20% mannitol solution and a 7.5% saline/6% dextran solution on increased intracranial pressure after brain injury. Crit Care Med. 2005 Jan;33(1):196-202; discussion 257-8.

Cruz J, Minoja G, Okuchi K, Facco E. Successful use of the new high-dose mannitol treatment in patients with Glasgow Coma Scale scores of 3 and bilateral abnormal pupillary widening: a randomized trial. J Neurosurg. 2004 Mar;100(3):376-83.

Tseng MY, Al-Rawi PG, Pickard JD, Rasulo FA, Kirkpatrick PJ. Effect of hypertonic saline on cerebral blood flow in poor-grade patients with subarachnoid hemorrhage. Stroke. 2003 Jun;34(6):1389-96. Epub 2003 May 1.

Study ID Numbers:	045-1503-266
Study First Received:	July 27, 2005
Last Updated:	August 10, 2005
ClinicalTrials.gov Identifier:	NCT00125229
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:

Hypertonic Saline
Mannitol
Intracranial hypertension
Cerebral blood flow
Traumatic brain injury

Study placed in the following topic categories:

Craniocerebral Trauma
Pseudotumor Cerebri
Vascular Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System

Brain Diseases
Intracranial Hypertension
Pseudotumor cerebri
Mannitol
Brain Injuries
Hypertension

Additional relevant MeSH terms:

Natriuretic Agents
Therapeutic Uses
Diuretics, Osmotic
Physiological Effects of Drugs
Diuretics

Nervous System Diseases
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009