Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

Stopped early · Phase 3

Conditions studied: Traumatic Brain Injury, Elevated Intracranial Pressure

In brief

This study examines the role of osmotic agents in controlling brain swelling in brain injured individuals. Two osmotic agents -- mannitol and hypertonic saline -- are in common use, and they will be compared in the context of a randomized clinical trial. The goal is to determine if these agent differ in their ability to control episodes of brain swelling.

Key facts

Study ID

NCT01111682

Run by

University of Cincinnati

People needed

5

Starts

2010-04-01

Expected to finish

2010-11-01

Last updated by the study team

2013-03-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• closed traumatic brain injury
• either (i) GCS score 3-8 (inclusive), or (ii) GCS motor score of 5 or less AND abnormal admission CT scan showing intracranial pathology
• hemodynamically stable with systolic blood pressure greater than 90 mmHg
• at least 1 reactive pupil
• age between 18y and 70y (inclusive)
• INR less than 1.5

You may not qualify if…

• actively on hypertonic saline or mannitol
• hypernatremia (>145 meq/L)
• anuric or with creatinine greater than or equal to 2.5
• known seizure disorder
• penetrating head trauma
• suspected anoxic events
• history of, or CT confirmation of, previous brain injury
• any injury that, in the opinion of the Principal Investigator, has a high likelihood of death with the first 72 hours post-injury
• any treatment, condition, or injury that contraindicates treatment with hypertonic saline

Where it is running

• University Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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