Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

Thomas Jefferson University

Status and phase: Unknown; Phase 1

Conditions: Increased Intracranial Pressure

Treatments: Drug: Hypertonic Saline, Mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT00359697

06U.132

Details and patient eligibility

About

The overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented SAH (by computed tomography or lumbar puncture), ICH, TBI or brain tumor
• Patient greater than or equal to 18 years of age
• ICP monitor in place
• ICP greater than 20mmHg, not related to a transient noxious stimulus and not responding to standard measures for controlling ICP (ventricular drainage, elevation of head of the bed and optimizing PaCO2)
• Patient or patient's legally authorized representative has provided written informed consent

Exclusion criteria

• Patient less than 18 years of age
• Lack of ICP monitoring
• Patient received Mannitol prior to placement of ICP monitor
• Baseline serum osmolarity of greater than 310 mOsm/L
• Patient is currently enrolled in another investigational drug or device study
• Congestive heart failure at time of enrollment
• Chronic renal failure on hemodialysis
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)