Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

University of Cincinnati

Status and phase

Terminated

Phase 3

Conditions

Traumatic Brain Injury

Elevated Intracranial Pressure

Treatments

Drug: Hypertonic Saline

Drug: Mannitol

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT01111682

Shutter-2010-01

Details and patient eligibility

About

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.

Full description

This single-center, randomized, open label trial will compare (i) 0.9% normal saline infusion and boluses of mannitol (control group) with (ii) 3% hypertonic saline, with intermittent boluses as needed, to treat elevated intracranial pressure (ICP) following severe traumatic brain injury.

Patients will be randomized to one of the two study arms following placement of an ICP monitor. Raised ICP will be defined as an ICP greater than 20 mmHG for 20 minutes or longer. In the event of such an event, the appropriate treatment will be administered.

The primary endpoint will be success in ICP control, operationalized as the proportion of time during which ICP is less than or equal to 20 mmHg during the first 120 hours following initiation of monitoring. Secondary endpoints include therapy intensity level, incidence of pre-determined severe adverse events, and long-term outcomes measured at 3 and 6 months post-injury.

Enrollment

5 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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