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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00447018
First received: March 12, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted

March 12, 2007
March 12, 2007
October 2002
Not Provided
Magnitude of ICP and of cerebral perfusion pressure (CPP) changes following osmotherapy during a study period of 120 min.
Same as current
No Changes Posted
  • 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).
Same as current
Not Provided
Not Provided
 
Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Intracranial Hypertension
  • Drug: 20% mannitol
  • Drug: 7.45% hypertonic saline solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00447018
0224
No
Not Provided
University Hospital, Grenoble
Not Provided
Principal Investigator: Jean-Francois Payen, MD, PhD University Hospital, Grenoble
University Hospital, Grenoble
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP