Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
NCT ID: NCT00125229
Last Updated: 2012-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
10 participants
OBSERVATIONAL
2005-08-31
2006-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mannitol vs HS to Treat ICHT After Severe TBI : Comparison on PtiO2 and Microdialysis Values
NCT01028339
Hypertonic Saline for Mild TBI in Pediatric Patients
NCT07060105
Osmotic Therapy for Treatment of Intracranial Hypertension for Traumatic Brain Injury
NCT01215019
Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
NCT00316004
Early Induced Hypernatremia for the Prevention and Management of Brain Edema
NCT02798601
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mannitol
Hypertonic Saline
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age \> 18 years
* Health care provider indicated a treatment of intracranial hypertension using hyperosmotic agent
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roman Hlatky, M.D.
Role: PRINCIPAL_INVESTIGATOR
Center for Neurosurgical Sciences - UTHSC San Antonio
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU)
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
045-1503-266
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.