Status:
WITHDRAWN
Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection
Lead Sponsor:
Duke University
Collaborating Sponsors:
The Medicines Company
Conditions:
Aorta Aneurysm
Dissection of Aorta
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
2\. Purpose of the Study - 1. To determine the feasibility of Clevidipine use for rapidly achieving and maintaining individually specified patient BP target ranges in the pre and postoperative period...
Eligibility Criteria
Inclusion
- Adult patients (age 18-80 years)
- Able to provide written consent
- Type I and Type II (Type A) aortic dissection or unstable chronic aortic aneurysm
- Patients expected to be admitted to ICU following aortic surgery for either dissection or aneurysm requiring acute management of elevated systolic blood pressure (consent obtained preoperatively)
Exclusion
- Unstable emergent dissections
- Evidence of end-organ dysfunction (ischemia of spinal cord, bowel, myocardium or renal)
- Active bleeding
- Allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis
- Women who are pregnant
- Female subjects of child bearing potential must have a blood serum pregnancy test performed prior to participating in this study and the results must be negative.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01480531
Start Date
December 1 2011
End Date
December 1 2012
Last Update
February 11 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710