Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring
Information source: University Hospital, Grenoble
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Brain Injury; Intracranial Hypertension
Intervention: variation of mannitol dose (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University Hospital, Grenoble Official(s) and/or principal investigator(s): Gilles Francony, MD, Principal Investigator, Affiliation: University Hospital, Grenoble
Summary
Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients
suffering intracranial hypertension following traumatic brain injury?
Clinical Details
Official title: Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: intracranial pressure
Secondary outcome: transcranial dopplerbrain PO2 MAP Heart Rate biology (blood gases, natremia, hematocrit) diuresis fluid requirement
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- adults
- severe traumatic brain injury
- intracranial hypertension requiring mannitol administration
Exclusion Criteria:
- impeding neurosurgery
- hemodynamic or respiratory severe failure
Locations and Contacts
Universitary Hospital, Grenoble 38043, France
Additional Information
Starting date: October 2008
Last updated: November 7, 2012
|