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Sponsored by: |
University Hospital, Grenoble |
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Information provided by: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT00447018 |
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 | Intervention | Phase |
---|---|---|
Intracranial Hypertension |
Drug: 20% mannitol Drug: 7.45% hypertonic saline solution |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Equimolar Doses of Mannitol and Hypertonic Saline in the Treatment of Elevated Intracranial Pressure |
Estimated Enrollment: | 20 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 0224 |
Study First Received: | March 12, 2007 |
Last Updated: | March 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00447018 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
intracranial pressure mannitol hypertonic saline solution brain injury |
traumatic brain injury Adult patients With elevation of intracranial pressure (ICP > 20 mmHg) |
Mannitol Diuretics Vascular Diseases Pseudotumor Cerebri Central Nervous System Diseases |
Cardiovascular Agents Brain Diseases Brain Injuries Intracranial Hypertension Hypertension |
Diuretics, Osmotic Nervous System Diseases Diuretics Physiological Effects of Drugs Pseudotumor Cerebri Vascular Diseases Central Nervous System Diseases Cardiovascular Agents |
Brain Diseases Pharmacologic Actions Intracranial Hypertension Mannitol Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Hypertension |