Clinical trial NCT00125229: Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
Official title: Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Traumatic Brain Injury
Intracranial Hypertension
Keywords: Hypertonic Saline
Mannitol
Intracranial hypertension
Cerebral blood flow
Traumatic brain injury
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2005-07-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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, 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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU)
state: Texas
Study officials:
affiliation: Center for Neurosurgical Sciences - UTHSC San Antonio
name: Roman Hlatky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.3171/jns.1977.47.4.0503.
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citation: 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. doi: 10.1097/01.CCM.0000063268.91710.DF.
citation: 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. doi: 10.1097/01.ccm.0000150269.65485.a6.
citation: 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. doi: 10.3171/jns.2004.100.3.0376.
citation: 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. doi: 10.1161/01.STR.0000071526.45277.44. Epub 2003 May 1.