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Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring

This study has been terminated.
(evolution of patient's care allows no more recruitment)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00795587
First received: November 20, 2008
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?


Condition Intervention Phase
Traumatic Brain Injury
Intracranial Hypertension
 Drug: variation of mannitol dose
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension

Resource links provided by NLM:

Drug Information available for: Mannitol
U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • intracranial pressure [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • transcranial doppler [ Time Frame: 2 h ] [ Designated as safety issue: Yes ]
  • brain PO2 [ Time Frame: 2h ] [ Designated as safety issue: Yes ]
  • MAP [ Time Frame: 2h ] [ Designated as safety issue: Yes ]
  • Heart Rate [ Time Frame: 2h ] [ Designated as safety issue: Yes ]
  • biology (blood gases, natremia, hematocrit) [ Time Frame: 2h ] [ Designated as safety issue: No ]
  • diuresis [ Time Frame: 2h ] [ Designated as safety issue: Yes ]
  • fluid requirement [ Time Frame: 2h ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: October 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: mannitol high dose
mannitol 20% 0,8 g/ kg on minutes
 Drug: variation of mannitol dose
in case of intracranial hypertension up to 20 mmHg lasting more than 10 minutes and without nociceptive stimulation or systemic instability: injection of either 0.4 g/ kg or 0.8 g/ kg of mannitol 20% (randomized) on 20 minutes, with monitoring of neurologic, systemic and biologic datas during 120 minutes
Active Comparator: mannitol low dose
mannitol 20% 0,4 g/ kg on minutes
 Drug: variation of mannitol dose
in case of intracranial hypertension up to 20 mmHg lasting more than 10 minutes and without nociceptive stimulation or systemic instability: injection of either 0.4 g/ kg or 0.8 g/ kg of mannitol 20% (randomized) on 20 minutes, with monitoring of neurologic, systemic and biologic datas during 120 minutes

Detailed Description:

traumatic brain injury intracranial hypertension 0,4 g/ kg vs 0,8 g/ kg (randomized) on 20 minutes monitoring: ICP, transcranial doppler, brain pO2, MAP, HR, diuresis, biology duration: 2 hours

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults
  • severe traumatic brain injury
  • intracranial hypertension requiring mannitol administration

Exclusion Criteria:

  • impeding neurosurgery
  • hemodynamic or respiratory severe failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795587

Locations
France
Universitary Hospital
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Gilles Francony, MD University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00795587     History of Changes
Other Study ID Numbers: 0816, 2008-004979-21
Study First Received: November 20, 2008
Last Updated: November 7, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hypertension
Intracranial Hypertension
Brain Injuries
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
 Wounds and Injuries
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013