Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure

March 12, 2007 updated by: University Hospital, Grenoble

Equimolar Doses of Mannitol and Hypertonic Saline in the Treatment of Elevated Intracranial Pressure

The purpose of this study is to determine whether mannitol is as effective as hypertonic saline solution in the treatment of elevated intracranial pressure in patients with brain injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Elevation of intracranial pressure (ICP) to more than 20 mmHg plays a major role in the worsening of the neurological status through the impairment of brain perfusion. In an effort to reduce the intensity and the time spent with increased ICP, infusion of mannitol has been the recommended first-line agent for years. The growing interest in the use of hypertonic saline solutions (HSS) in this clinical setting has, however, challenged the use of mannitol. Because mannitol and HSS may differ regarding their clinically relevant mechanisms of action, there is a need to determine which osmotic compound could be the most appropriate in patients with elevated ICP. We conduct thus a parallel, randomized controlled trial comparing the effects of an equimolar infusion of 20% mannitol or 7.45% HSS without colloid in patients with elevated ICP. The primary end point of this trial is the magnitude of ICP and of cerebral perfusion pressure (CPP) changes following treatment during a study period of 120 min.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Hôpital Michallon

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:

  • age 18 or older
  • sustained elevated intracranial pressure to more than 20 mmHg for more than 10 min
  • mechanically ventilated in stable conditions for more than 2 hours prior to the study
  • serum osmolality ranged between 280 and 320 mOsm/kg

Exclusion Criteria:

  • imminent cranial or extracranial surgery
  • leakage or drainage of cerebral spinal fluid
  • unstable respiratory and hemodynamic conditions
  • oliguric renal failure
  • anemia
  • use of mannitol or HSS in the previous 6 hours
  • concomitant use of thiopentone

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Magnitude of ICP and of cerebral perfusion pressure (CPP) changes following osmotherapy during a study period of 120 min.

Secondary Outcome Measures

Outcome Measure
Effects of treatment on blood flow velocities (FV) of middle cerebral artery using continuous transcranial doppler.
Effects of treatment on brain oxygenation using brain tissue oxygen tension (PbrO2) probe.
Effects of treatment on biochemical data (serum sodium and osmolality, urine output).

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Francois Payen, MD, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

October 1, 2002

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Estimate)

March 13, 2007

Last Update Submitted That Met QC Criteria

March 12, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0224

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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