Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

Increased Intracranial Pressure Clinical Trial

Official title:

Prospective, Randomized Clinical Trialto Compare Mannitol and Hypertonic Saline for Treatment of Increased Intracranial Pressure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00359697
• Other study ID #: 06U.132
• Status: Not yet recruiting
• Phase: Phase 1
• First received: August 1, 2006
• Last updated: November 5, 2014

Study information

• Verified date: November 2014
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Increased Intracranial Pressure
• Intracranial Hypertension

Intervention

Drug:
• Hypertonic Saline, Mannitol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of ICP below treatment threshold (less than 20 mmHg)
Secondary	Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality