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

Beth Israel Lahey Health

Status: Withdrawn

Conditions: Elevated Intracranial Pressure

Treatments: Drug: Mannitol; Drug: hypertonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01108744

2009P000313

Details and patient eligibility

About

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

Full 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?

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

hypertonic saline

Active Comparator group

Description:

3% hypertonic saline, dosed by ideal patient weight

Treatment:

Drug: hypertonic saline

Mannitol

Active Comparator group

Description:

20% mannitol, dosed by patient's ideal body weight

Treatment:

Drug: Mannitol