Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure - Full Text View

Sponsored by:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00447018

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 IV

MedlinePlus related topics: High Blood Pressure Traumatic Brain Injury

Drug Information available for: Mannitol

U.S. FDA Resources

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

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

Magnitude of ICP and of cerebral perfusion pressure (CPP) changes following osmotherapy during a study period of 120 min.

Secondary Outcome Measures:

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

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447018

Locations

France
Hopital Michallon
Grenoble, France, 38043

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator:

Jean-Francois Payen, MD, PhD

University Hospital, Grenoble

More Information

Publications of Results:

Battison C, Andrews PJ, Graham C, Petty T. Randomized, controlled trial on the effect of a 20% mannitol solution and a 7.5% saline/6% dextran solution on increased intracranial pressure after brain injury. Crit Care Med. 2005 Jan;33(1):196-202; discussion 257-8.

Vialet R, Albanese J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7.

Study ID Numbers:	0224
Study First Received:	March 12, 2007
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00447018
Health Authority:	France: Afssaps - French Health Products Safety Agency

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)

Study placed in the following topic categories:

Pseudotumor cerebri
Mannitol
Vascular Diseases
Pseudotumor Cerebri
Central Nervous System Diseases

Brain Diseases
Brain Injuries
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:

Natriuretic Agents
Therapeutic Uses
Diuretics, Osmotic
Physiological Effects of Drugs
Diuretics

Nervous System Diseases
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009