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Completed

NCT Number: NCT00447018

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Michallon

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

20% mannitol

Drug

7.45% hypertonic saline solution

Drug

Primary outcomes

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

Secondary outcomes

  1. Effects of treatment on blood flow velocities (FV) of middle cerebral artery using continuous transcranial doppler.

  2. Effects of treatment on brain oxygenation using brain tissue oxygen tension (PbrO2) probe.

  3. Effects of treatment on biochemical data (serum sodium and osmolality, urine output).

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Equimolar Doses of Mannitol and Hypertonic Saline in the Treatment of Elevated Intracranial Pressure

Important dates

Study start
2002
Study completion
2005
First posted
Mar 13, 2007
Registry last updated
Mar 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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