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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447018
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : March 13, 2007
Information provided by:
University Hospital, Grenoble

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intracranial Hypertension Drug: 20% mannitol Drug: 7.45% hypertonic saline solution Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Equimolar Doses of Mannitol and Hypertonic Saline in the Treatment of Elevated Intracranial Pressure
Study Start Date : October 2002
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447018

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Hopital Michallon
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
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Principal Investigator: Jean-Francois Payen, MD, PhD University Hospital, Grenoble
Publications of Results:
Layout table for additonal information Identifier: NCT00447018    
Other Study ID Numbers: 0224
First Posted: March 13, 2007    Key Record Dates
Last Update Posted: March 13, 2007
Last Verified: March 2007
Keywords provided by University Hospital, Grenoble:
intracranial pressure
hypertonic saline solution
brain injury
traumatic brain injury
Adult patients
With elevation of intracranial pressure (ICP > 20 mmHg)
Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs