NCT01111682

Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Traumatic Brain Injury
• Elevated Intracranial Pressure

Interventions

Type	Name	Description
DRUG	Mannitol	0.9% normal saline infusion and boluses of mannitol
DRUG	Hypertonic Saline	3% hypertonic saline continuous infusion, with intermittent boluses as needed

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-04-27
• Last updated: 2013-03-05

Locations

1 site across 1 country: United States