Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Completed

Phase 4

Conditions

Intracranial Hypertension

Treatments

Drug: 7.45% hypertonic saline solution

Drug: 20% mannitol

Study type

Interventional

Funder types

Other

Identifiers

NCT00447018

0224

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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