Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Aorta AneurysmDissection of Aorta
Interventions
DRUG

Clevidipine

"Clevidipine administration begins in the ER or ICU~* Clevidipine is again administered post op when blood pressure control is required.~* Clevidipine will be administered by an infusion pump via either a central line or a peripheral IV as follows:~* Clevidipine will be initiated at an infusion rate of 0.4 μg•kg-1•min-1 and will be titrated as tolerated in doubling increments every 90 s up to 3.2 μg•kg-1•min-1.~* Infusion rates above 3.2 μg•kg-1•min-1 will be guided by the patient's response and permitted in serial increments of 1.5 μg•kg-1•min-1.~* Infusion rates between 4.4 and 8.0 μg•kg-1•min-1 will be administered for no longer than 2 h.~As blood pressure approaches goal, increase dose by less than double and lengthen time between does adjustments to every 5-10 minutes (a 1-2 mg/hr increase will generally result in a 2-4 mm Hg reduction in SBP)"

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

The Medicines Company

INDUSTRY

lead

Duke University

OTHER