Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring
Primary Purpose
Traumatic Brain Injury, Intracranial Hypertension
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
variation of mannitol dose
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- adults
- severe traumatic brain injury
- intracranial hypertension requiring mannitol administration
Exclusion Criteria:
- impeding neurosurgery
- hemodynamic or respiratory severe failure
Sites / Locations
- Universitary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
mannitol high dose
mannitol low dose
Arm Description
mannitol 20% 0,8 g/ kg on minutes
mannitol 20% 0,4 g/ kg on minutes
Outcomes
Primary Outcome Measures
intracranial pressure
Secondary Outcome Measures
transcranial doppler
brain PO2
MAP
Heart Rate
biology (blood gases, natremia, hematocrit)
diuresis
fluid requirement
Full Information
NCT ID
NCT00795587
First Posted
November 20, 2008
Last Updated
November 7, 2012
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT00795587
Brief Title
Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring
Official Title
Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
evolution of patient's care allows no more recruitment
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Intracranial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mannitol high dose
Arm Type
Active Comparator
Arm Description
mannitol 20% 0,8 g/ kg on minutes
Arm Title
mannitol low dose
Arm Type
Active Comparator
Arm Description
mannitol 20% 0,4 g/ kg on minutes
Intervention Type
Drug
Intervention Name(s)
variation of mannitol dose
Intervention Description
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 Measure Information:
Title
intracranial pressure
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
transcranial doppler
Time Frame
2 h
Title
brain PO2
Time Frame
2h
Title
MAP
Time Frame
2h
Title
Heart Rate
Time Frame
2h
Title
biology (blood gases, natremia, hematocrit)
Time Frame
2h
Title
diuresis
Time Frame
2h
Title
fluid requirement
Time Frame
2h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults
severe traumatic brain injury
intracranial hypertension requiring mannitol administration
Exclusion Criteria:
impeding neurosurgery
hemodynamic or respiratory severe failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Francony, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitary Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
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Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring
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