Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Mannitol

Criteria

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