Mannitol Versus Hypertonic Saline Solution 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.
Drug: 20% mannitol
Drug: 7.45% hypertonic saline solution
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Equimolar Doses of Mannitol and Hypertonic Saline in the Treatment of Elevated Intracranial Pressure|
- Magnitude of ICP and of cerebral perfusion pressure (CPP) changes following osmotherapy during a study period of 120 min.
- 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).
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||June 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447018
|Grenoble, France, 38043|
|Principal Investigator:||Jean-Francois Payen, MD, PhD||University Hospital, Grenoble|