Overview

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