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

2014-08-27 03:14:26 | BioPortfolio

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

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?

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Elevated Intracranial Pressure

Intervention

hypertonic saline, mannitol

Location

Beth Israel Deaconess Medical Center
Boston
Massachusetts
United States
02215

Status

Not yet recruiting

Source

Beth Israel Deaconess Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:26-0400

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PubMed Articles [7810 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

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