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Cerebral Hemodynamic Effects of Hypertonic Solutions in Severly Head-Injured Patients - Article


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Traumatic Brain Injury

 




Clinical Trial: Cerebral Hemodynamic Effects of Hypertonic Solutions in Severly Head-Injured Patients

This study is not yet open for patient recruitment.
Verified by The University of Texas Health Science Center at San Antonio July 2005

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

Clinical study comparing physiologic effects of two hypertonic solutions (Mannitol, Hypertonic Saline) with particular emphasis on changes in cerebral blood flow in patients with intracranial hypertension following serious traumatic brain injury.
Condition Intervention Phase
Traumatic Brain Injury
Intracranial Hypertension
 Drug: Mannitol vs. Hypertonic Saline
Phase IV

MedlinePlus related topics:  Brain Diseases;   Head and Brain Injuries

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Further Study Details: 

Expected Total Enrollment:  10

Study start: August 2005;  Expected completion: June 2006
Last follow-up: June 2006;  Data entry closure: June 2006

Studies 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. Study is noninvasive and the study protocol doesn''''t hamper, in any way, standard care of treatment for these patients.

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Patients with severe TBI (motor 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00125229

Roman Hlatky, M.D.      210-567-5625    hlatky@uthscsa.edu

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

Study chairs or principal investigators

Roman Hlatky, M.D.,  Principal Investigator,  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
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125229
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-02

Resources

  • Brain Injury (Centers for Disease Control and Prevention)
  • Brain Injury (National Institute of Neurological Disorders and Stroke)


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Page Updated: October 3, 2005
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