Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

November 5, 2014 updated by: Thomas Jefferson University

Prospective, Randomized Clinical Trialto Compare Mannitol and Hypertonic Saline for Treatment of Increased Intracranial Pressure

The overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented SAH (by computed tomography or lumbar puncture), ICH, TBI or brain tumor
  • Patient greater than or equal to 18 years of age
  • ICP monitor in place
  • ICP greater than 20mmHg, not related to a transient noxious stimulus and not responding to standard measures for controlling ICP (ventricular drainage, elevation of head of the bed and optimizing PaCO2)
  • Patient or patient's legally authorized representative has provided written informed consent

Exclusion Criteria:

  • Patient less than 18 years of age
  • Lack of ICP monitoring
  • Patient received Mannitol prior to placement of ICP monitor
  • Baseline serum osmolarity of greater than 310 mOsm/L
  • Patient is currently enrolled in another investigational drug or device study
  • Congestive heart failure at time of enrollment
  • Chronic renal failure on hemodialysis
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of ICP below treatment threshold (less than 20 mmHg)

Secondary Outcome Measures

Outcome Measure
Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Robert H Rosenwasser, MD, Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 1, 2006

First Submitted That Met QC Criteria

August 1, 2006

First Posted (ESTIMATE)

August 2, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06U.132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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