Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure
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Purpose
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 4 |
| Study Type: | Interventional |
| 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).
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00447018 History of Changes |
| Other Study ID Numbers: | 0224 |
| Study First Received: | March 12, 2007 |
| Last Updated: | March 12, 2007 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Grenoble:
|
intracranial pressure mannitol hypertonic saline solution brain injury |
traumatic brain injury Adult patients With elevation of intracranial pressure (ICP > 20 mmHg) |
Additional relevant MeSH terms:
|
Hypertension Intracranial Hypertension Vascular Diseases Cardiovascular Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Mannitol |
Diuretics, Osmotic Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013