WithdrawnNot Applicable

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

Stopped: Timeline to consent prior to intervention start was unfeasible.

United States0Started 2012-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percent reduction of ICP from baseline

Timeframe: 30 minutes from completion of medication administration

Trial details

NCT IDNCT01108744

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01

View on ClinicalTrials.gov More Elevated Intracranial Pressure trials