Clinical Trial: Hypernatremia for the Prevention and Treatment of Cerebral Edema in Traumatic Brain Injury

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Randomized, Open Label Clinical Trial of Sustained Hypernatremia for the Prevention and Treatment of Cerebral Edema in Traumatic Brain Injury

Brief Summary:

Cerebral edema is seen heterogenous group of neurological disease states that mainly fall under the categories of metabolic, infectious, neoplasia, cerebrovascular, and traumatic brain injury disease states. Regardless of the driving force, cerebral edema is defined as the accumulation of fluid in the brain's intracellular and extracellular spaces. This occurs secondary to alterations in the complex interplay between four distinct fluid compartments within the cranium. In any human cranium; fluid is contained in the blood, the cerebrospinal fluid, interstitial fluid of the brain parenchyma, and the intracellular fluid of the neurons and glia. Fluid movement occurs normally between these compartments and depends on specific concentrations of solutes (such as sodium) and water. In brain-injured states, the normal regulation of this process is disturbed and cerebral edema can develop. Cerebral edema leads to increased intracranial pressure and mortality secondary to brain tissue compression, given the confines of the fixed-volume cranium. Additionally, secondary neuronal dysfunction or death can occur at the cellular level secondary to the disruption of ion gradients that control metabolism and function.

While studies utilizing bolus dosing of hyperosmolar therapy to target signs or symptoms of increased intracranial pressure secondary to cerebral edema are numerous, there is a paucity of studies relating to continuous infusion of hyperosmolar therapy for targeted sustained hypernatremia for the prevention and treatment of cerebral edema. The investigators hypothesize that induced, sustained hypernatremia following traumatic brain injury will decrease the rate of cerebral edema formation and improve patient outcomes.

Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome:

• Primary Efficacy Objective [ Time Frame: 72 hours ; 120 hours ; 30 days ]
  The primary efficacy objective of this study is to assess whether patients with severe TBI treated with sustained hypernatremia will show a decrease in neuroimaging defined edema compared to patients treated as the current standard of care.
• Primary Safety Objective [ Time Frame: Through 30 days ]
  The primary safety objective is to assess the safety and tolerability of sustained hypernatremia compared to the goal of avoiding hyponatremia in patients with severe traumatic brain injury. Safety will be assessed by a review of the incidence of mortality and adverse events, as well as by analysis of relevant laboratory data.

Original Primary Outcome: Same as current

Current Secondary Outcome: Short term neurological outcome [ Time Frame: 30 days ]

Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: May 22, 2012
Date Started: July 2012
Date Completion: August 2013
Last Updated: December 9, 2016
Last Verified: December 2016