Status:
WITHDRAWN
The Effect of Clevidipine on Intracranial Pressure and Cerebral Perfusion Pressure (CCP) in Brain Injured Patients
Lead Sponsor:
Columbia University
Collaborating Sponsors:
The Medicines Company
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with acute brain injury are at risk for complications such as increased pressure in the brain (intracranial pressure (ICP)), decreased blood flow, bleeding, and brain swelling (cerebral edema...
Detailed Description
This is an open-label, single arm, single center study in patients with hypertension in the setting of an acute brain injury. Approximately 15 patients admitted to the Columbia University Neurocritica...
Eligibility Criteria
Inclusion
- Coma (Glasgow Coma Scale (GCS) less than or equal to 8) due to any cause
- Male and Female patients \> 18 years.
- Mechanically ventilated
- Functional multimodality neuromonitoring bundle (intracranial pressure (ICP) monitor, Hemedex, Licox, and microdialysis) placed in the course of routine clinical management
- Patient is hypertensive at the time of enrollment (CPP \>100 mm Hg and/or SBP \>180mmHg) and the decision has been made to start clevidipine butyrate in order to maintain CPP within 70-90 mm Hg and/or SBP \<180mmHg
- Patient has a minimum of 60 min of baseline brain multimodality monitoring prior to initiation of clevidipine -
Exclusion
- Absence of negative pregnancy test in women of child-bearing potential.
- FiO2 \>50%
- Unable to maintain stable sedative infusion rates for 4 hours
- Unable to maintain stable ventilator setting for 4 hours
- Unable to maintain stable insulin infusion rates for 4 hours
- Patient is currently receiving nicardipine infusion
- Allergy to soybean oil or lecithin
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01526876
Start Date
November 1 2011
End Date
December 19 2012
Last Update
July 17 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.