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

• Status: Withdrawn
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Mannitol

Criteria

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