A Phase 4 interventional study of 20% mannitol and 7.45% hypertonic saline solution in Intracranial Hypertension, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-03-13.
Sponsored by University Hospital, Grenoble · Phase 4, Interventional, and Treatment
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.
185 studies on the registry are indexed under Intracranial Hypertension; 45 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 95 interventional studies indexed under Intracranial Hypertension.
Browse Intracranial Hypertension studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
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Exclusion Criteria:
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).
This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble