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

Withdrawn before enrolling · Not applicable

Conditions studied: Elevated Intracranial Pressure

In brief

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

Key facts

Study ID

NCT01108744

Run by

Beth Israel Deaconess Medical Center

People needed

0

Starts

2012-01-01

Expected to finish

2014-01-01

Last updated by the study team

2017-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• elevated ICP requiring ICP monitoring
• ICP ≥ 25 mmHg 5 min after ICP bolt or EVD placement

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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