Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Increased Intracranial Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Hypertonic Saline, Mannitol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No