Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

Phase 1

• Conditions: Increased Intracranial Pressure

• Registration Number: NCT00359697
• Lead Sponsor: Thomas Jefferson University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-01
• Study First Submitted QC: 2006-08-01
• Study First Posted: 2006-08-02
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of ICP below treatment threshold (less than 20 mmHg)

Secondary Outcome Measures

Name	Time	Method
Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality