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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00447018
First received: March 12, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 24, 2014