Traumatic Brain InjuryNCT00125229
Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
An observational study of Traumatic Brain Injury and Intracranial Hypertension, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injury, Intracranial Hypertension
- What is being tested?
- Mannitol and Hypertonic Saline
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU)
San Antonio, Texas, 78229
About this study
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).
Read the 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.
- Conditions
- Traumatic Brain Injury, Intracranial Hypertension
- Being tested
- Mannitol, Hypertonic Saline
- Keywords
- Hypertonic Saline, Mannitol, Intracranial hypertension, Cerebral blood flow, Traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
Hypertonic SalineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2006
- Study completionJun 2006
Why it stopped: Dr. Hladky died Sept 2006 prior to study completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roman Hlatky, M.D., Principal investigator, Center for Neurosurgical Sciences - UTHSC San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125229
- Sponsor's protocol ID
- 045-1503-266
- Status last verified
- Jun 2012
- First submitted
- 27 Jul 2005
- Last updated
- 26 Jun 2012
- Results posted
- No
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. doi: 10.3171/jns.1977.47.4.0503.
PubMed 903804Doyle 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.
PubMed 11242309Wade 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.
PubMed 9308620Valadka 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.
PubMed 10809326Berger 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.
PubMed 7526628Worthley 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.
PubMed 3343621Qureshi 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.
PubMed 9504569Qureshi 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.
PubMed 10232539Vialet 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.
PubMed 12794404Battison 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.
PubMed 15644669Cruz 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.
PubMed 15035271Tseng 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.
PubMed 12730557
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
- ClinicalTrials.gov ID
- NCT00125229
- Acronym / sponsor ID
- 045-1503-266
- Conditions
- Traumatic Brain Injury, Intracranial Hypertension
- Keywords
- Hypertonic Saline, Mannitol, Intracranial hypertension, Cerebral blood flow, Traumatic brain injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Dr. Hladky died Sept 2006 prior to study completion
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 29 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mannitol | Drug | – |
| Hypertonic Saline | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Dr. Hladky died Sept 2006 prior to study completion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
- Background: PubMed 903804Miller 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.
- Background: PubMed 11242309Doyle 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.
- Background: PubMed 9308620Wade 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.
- Background: PubMed 10809326Valadka 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.
- Background: PubMed 7526628Berger 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.
- Background: PubMed 3343621Worthley 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.
- Background: PubMed 9504569Qureshi 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.
- Background: PubMed 10232539Qureshi 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.
- Background: PubMed 12794404Vialet 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.
- Background: PubMed 15644669Battison 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.
- Background: PubMed 15035271Cruz 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.
- Background: PubMed 12730557Tseng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Hlatky, M.D. principal investigator
Center for Neurosurgical Sciences - UTHSC San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Intracranial Hypertension, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Dr. Hladky died Sept 2006 prior to study completion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125229, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.