Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: United States Department of Defense
• Treatments: Mannitol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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