Double Blind Study of Hypertonic Saline vs Mannitol in the Management of Increased Intracranial Pressure (ICP).

Double Blind Study of Hypertonic Saline vs Mannitol in the Management of Increased Intracranial Pressure (ICP).

Double Blind Study of Hypertonic Saline vs Mannitol in the Management of Increased Intracranial Pressure (ICP).

The study goal is to compare the management of increased intra-cranial pressure (ICP) using 3% hypertonic saline vs. mannitol (given in same osmolar loads). Primary hypothesis: 1. Hypertonic saline will be non-inferior to mannitol in decreasing elevated ICP. Secondary hypotheses: Hypertonic saline therapy will result with fewer complications than mannitol ICP reduction duration will be longer using hypertonic saline when compared with mannitol

There is growing evidence in the literature indicating that ICP and Cerebral Perfusion Pressure measurements may not be sufficient in the management of elevated ICP. Based on this evidence, monitoring of partial brain tissue oxygenation has gain acceptance among neurosurgeons and neurointensivists, and has become a standard of care monitor in some centers across the country. There is, however, insufficient information in the literature describing the effects of hyperosmolar medications on regional brain tissue oxygenation. We intend to undertake this non-inferiority, prospective, randomized double-blind study to answer very important clinical questions not yet answered in the literature: Will hypertonic saline therapy, given at equiosmolar load, be non-inferior to mannitol in reducing elevated ICP?

clinical trial, mannitol, intracranial pressure (ICP), hypertonic saline, cerebral edema, traumatic brain injury (TBI)

Rebound intracranial hypertension defined as ICP > 25 mmHg for more than 10 minutes following ICP stabilization

acute kidney injury as defined by an increase in creatinine x 2 or GFR decrease > 50% or urine output < 0.5 ml/kg/h for 12 hours, compared to baseline, as per RIFLE criteria hypotensive episodes (SBP < 90 mmHg for more than 10 minutes) hemodynamic instability as measured by decrease of cardiac output by more than 15% within two hours following medication administration pulmonary edema as defined by ELWI I> 10

Inclusion Criteria: Age ≥ 18 years elevated ICP requiring ICP monitoring ICP ≥ 25 mmHg 5 min after ICP bolt or EVD placement Exclusion Criteria: Requiring decompressive craniotomy or post decompressive craniotomy Hyponatremia (sodium level < 125 mEq/L) Hypernatremia (sodium > 155 mmol/L) Serum osmolality ≤ 250 mOsm/kg Serum osmolality ≥ 320 mOsm/kg Physical exam compatible with brain death Patients on hemodialysis with end-stage renal disease

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