ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00795587
Recruitment Status : Terminated (evolution of patient's care allows no more recruitment)
First Posted : November 21, 2008
Last Update Posted : November 8, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Intracranial Hypertension Drug: variation of mannitol dose Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension
Study Start Date : October 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. transcranial doppler [ Time Frame: 2 h ]
  2. brain PO2 [ Time Frame: 2h ]
  3. MAP [ Time Frame: 2h ]
  4. Heart Rate [ Time Frame: 2h ]
  5. biology (blood gases, natremia, hematocrit) [ Time Frame: 2h ]
  6. diuresis [ Time Frame: 2h ]
  7. fluid requirement [ Time Frame: 2h ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795587


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

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00795587     History of Changes
Other Study ID Numbers: 0816
2008-004979-21 ( EudraCT Number )
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: November 8, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Hypertension
Brain Injuries
Brain Injuries, Traumatic
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