Hypernatremia for the Prevention and Treatment of Cerebral Edema in Traumatic Brain Injury
Traumatic Brain Injury, Subdural Hematoma, Cerebral Contusion
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Brain Injuries, Hematoma, subdural, Decompressive Craniectomy, Saline solution, hypertonic, Hypernatremia, Intracranial hemorrhages, Head Injuries, closed, Intracranial pressure, Brain edema, Critical care, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Wounds and Injuries, Physiological Effects of Drugs, Pharmacologic Actions
Eligibility Criteria
Inclusion Criteria:
- Adults (18 - 60 years old)
- Severe traumatic brain injury with intracranial pressure monitoring
- Initial GCS 5-8 (obtained free of the effects of neuromuscular blockade or sedatives)
- Clearly defined time of injury no more than 8 hours before administration of study drug
- Written consent obtained from legally authorized representative (LAR)
Severe swelling prone injury patterns:
- Contusion - frontal or temporal (> 20 cc)
- Acute convexity subdural hematoma with any evidence of midline shift
Exclusion Criteria:
- Patients undergoing emergent (within 15 minutes) or urgent neurosurgery (within 4 hours) following emergency department arrival (bedside procedures, such as intracranial pressure monitor placement are excluded)
- Posterior fossa lesions
- Penetrating brain injury
- Spinal column instability and/or spinal cord injury with neurological deficit
- Pregnant
- Concomitant severe nonsurvivable injury
- Acute renal failure ; Chronic renal failure (serum creatinine of > 2.5 mg/dL, history of ongoing dialysis, glomerular filtration rate <30mL/min/1.73 m2); Severe pulmonary edema; Severe heart failure; Severe liver failure (AST, ALT, or bilirubin > 2 times normal)
- Known use of warfarin, clopidogrel, prasugrel, cilostazol, heparin, low molecular weight heparin, heparinoids, abciximab or similar antiplatelet agents
- Treatment with another investigational drug within the prior 30 days
- Systolic blood pressure < 90 mm HG not responsive to fluid resuscitation
- INR > 1.4
- Hospitalization for brain injury or neurological disease within previous 3 years
- Admission serum sodium < 135 mmol/L
- > 8 hours from the time of injury to admission
- Fix/dilated pupil suspected to be secondary to brainstem compression
- Duret (brainstem) hemorrhage indicating brainstem herniation
- PaO2 < 60 mmHg on admission (when blood gases are drawn as standard of care)
- Prisoner or other persons unable to make a true, voluntary and uncoerced decision whether or not to participate in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard Care
Induced Hypernatremia
Patients will be managed to maintain a goal serum sodium of > 135 mmol/L , a well recognized value in the management of severe traumatic brain injury.
Patients will be treated with induced, sustained hypernatremia for 5 days following injury by using hypertonic saline to target a goal serum sodium of 150-160 mmol/L