Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

Traumatic Brain Injury Clinical Trial

Official title: Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Elevated Intracranial Pressure
• Intracranial Hypertension
• Traumatic Brain Injury

• NCT number: NCT01111682
• Study type: Interventional
• Source: University of Cincinnati
• Status: Terminated
• Phase: Phase 3
• Start date: April 2010
• Completion date: November 2010