Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
Overview[ - collapse ][ - ]
| Purpose | 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). |
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| Condition | Traumatic Brain Injury Intracranial Hypertension |
| Intervention | Drug: Mannitol Drug: Hypertonic Saline |
| Phase | Phase 4 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Responsible Party | The University of Texas Health Science Center at San Antonio |
| ClinicalTrials.gov Identifier | NCT00125229 |
| First Received | July 27, 2005 |
| Last Updated | June 22, 2012 |
| Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 27, 2005 |
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| Last Updated Date | June 22, 2012 |
| Start Date | August 2005 |
| Estimated Primary Completion Date | June 2006 |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients |
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| Official Title | Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients |
| 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. |
| Study Type | Observational |
| Study Phase | Phase 4 |
| Study Design | Observational Model: Case-Only, Time Perspective: Prospective |
| Condition |
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| Intervention | Drug: Mannitol Drug: Hypertonic Saline |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 10 |
| Estimated Completion Date | June 2006 |
| Estimated Primary Completion Date | June 2006 |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00125229 |
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| Other Study ID Numbers | 045-1503-266 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | The University of Texas Health Science Center at San Antonio |
| Study Sponsor | The University of Texas Health Science Center at San Antonio |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Roman Hlatky, M.D. Center for Neurosurgical Sciences - UTHSC San Antonio |
| Verification Date | June 2012 |
Locations[ + expand ][ + ]
| Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU) | San Antonio, Texas, United States, 78229 |
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