Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

NCT01111682 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2013-03-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Mannitol

0.9% normal saline infusion and boluses of mannitol

DRUG

Hypertonic Saline

3% hypertonic saline continuous infusion, with intermittent boluses as needed

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED
  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Lori Shutter, MD · Department of Neurology College of Medicine University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01111682 on ClinicalTrials.gov