NCT00125229

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2005

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

10 months

First QC Date

July 27, 2005

Last Update Submit

June 22, 2012

Conditions

Traumatic Brain InjuryIntracranial Hypertension

Keywords

Hypertonic SalineMannitolIntracranial hypertensionCerebral blood flowTraumatic brain injury

Interventions

MannitolDRUG
Hypertonic SalineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU)

San Antonio, Texas, 78229, United States

Location

Related Publications (12)

  • 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.

    PMID: 903804BACKGROUND

  • 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. doi: 10.1097/00005373-200102000-00030. No abstract available.

    PMID: 11242309BACKGROUND

  • 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. doi: 10.1016/s0039-6060(97)90135-5.

    PMID: 9308620BACKGROUND

  • Valadka AB, Robertson CS. Should we be using hypertonic saline to treat intracranial hypertension? Crit Care Med. 2000 Apr;28(4):1245-6. doi: 10.1097/00003246-200004000-00069. No abstract available.

    PMID: 10809326BACKGROUND

  • 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. doi: 10.1007/978-3-7091-9334-1_135.

    PMID: 7526628BACKGROUND

  • 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. doi: 10.3171/jns.1988.68.3.0478.

    PMID: 3343621BACKGROUND

  • 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. doi: 10.1097/00003246-199803000-00011.

    PMID: 9504569BACKGROUND

  • 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. doi: 10.1097/00006123-199905000-00064.

    PMID: 10232539BACKGROUND

  • 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.

    PMID: 12794404BACKGROUND

  • 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.

    PMID: 15644669BACKGROUND

  • 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.

    PMID: 15035271BACKGROUND

  • 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.

    PMID: 12730557BACKGROUND

MeSH Terms

Conditions

Brain Injuries, TraumaticIntracranial Hypertension

Interventions

MannitolSaline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesHypertonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Roman Hlatky, M.D.

    Center for Neurosurgical Sciences - UTHSC San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2005

First Posted

July 29, 2005

Study Start

August 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations

US(1)