Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00125229

Enrollment

Registered

2005-07-29

Start date

2005-08-31

Completion date

2006-06-30

Last updated

2012-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hypertension, Traumatic Brain Injury

Keywords

Hypertonic Saline, Mannitol, Intracranial hypertension, Cerebral blood flow, Traumatic brain injury

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.

Interventions

DRUGMannitol

DRUGHypertonic Saline

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026