- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00795587
Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring
November 7, 2012 updated by: University Hospital, Grenoble
Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension
Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
3
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Grenoble, France, 38043
- Universitary Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adults
- severe traumatic brain injury
- intracranial hypertension requiring mannitol administration
Exclusion Criteria:
- impeding neurosurgery
- hemodynamic or respiratory severe failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: mannitol high dose
mannitol 20% 0,8 g/ kg on minutes
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
intracranial pressure
Time Frame: 2 hours
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
transcranial doppler
Time Frame: 2 h
|
2 h
|
brain PO2
Time Frame: 2h
|
2h
|
MAP
Time Frame: 2h
|
2h
|
Heart Rate
Time Frame: 2h
|
2h
|
biology (blood gases, natremia, hematocrit)
Time Frame: 2h
|
2h
|
diuresis
Time Frame: 2h
|
2h
|
fluid requirement
Time Frame: 2h
|
2h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gilles Francony, MD, University Hospital, Grenoble
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
November 20, 2008
First Submitted That Met QC Criteria
November 20, 2008
First Posted (Estimate)
November 21, 2008
Study Record Updates
Last Update Posted (Estimate)
November 8, 2012
Last Update Submitted That Met QC Criteria
November 7, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Hypertension
- Brain Injuries
- Brain Injuries, Traumatic
- Intracranial Hypertension
- Physiological Effects of Drugs
- Natriuretic Agents
- Diuretics, Osmotic
- Diuretics
- Mannitol
Other Study ID Numbers
- 0816
- 2008-004979-21 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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