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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
  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
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:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • intracranial pressure [ Time Frame: 2 hours ]

Secondary Outcome Measures:
  • transcranial doppler [ Time Frame: 2 h ]
  • brain PO2 [ Time Frame: 2h ]
  • MAP [ Time Frame: 2h ]
  • Heart Rate [ Time Frame: 2h ]
  • biology (blood gases, natremia, hematocrit) [ Time Frame: 2h ]
  • diuresis [ Time Frame: 2h ]
  • fluid requirement [ Time Frame: 2h ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: 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

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

Additional relevant MeSH terms:
Hypertension
Brain Injuries
Intracranial Hypertension
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

ClinicalTrials.gov processed this record on February 27, 2017