NCT01108744

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: 1. Hypertonic saline therapy will result with fewer complications than mannitol 2. ICP reduction duration will be longer using hypertonic saline when compared with mannitol

Detailed description

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?

Conditions

• Elevated Intracranial Pressure

Interventions

Type	Name	Description
DRUG	hypertonic saline	3% hypertonic saline, dosed by ideal patient weight
DRUG	Mannitol	Mannitol 20% intravenous solution, dosed by patient's ideal body weight

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2010-04-22
• Last updated: 2017-03-16

Locations

1 site across 1 country: United States