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

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 periods of
aortic aneurysm and dissection management.

2. To determine the safety of Clevidipine use in the pre and postoperative periods of
aneurysm and dissection management

3. Background & Significance - Surgical treatments for persons with aortic root/arch
dissection or aneurysm have significantly improved survival. However, critical in
management of these patients is precise control of blood pressure (BP). With increasing
BP, both acute and chronic, the risk of fatal and nonfatal vascular complications is
imminent. Similarly, with excessive lowering of arterial pressures, cerebral, spinal
cord, cardiac, and renal ischemic hypoperfusion is also noteworthy. Typically, the
target systolic blood pressure range for these patients is 100-120 mmHg.

Several different classes of vasoactive agents are in current use to acutely manage BP
but none possess the optimal profile of an ideal vasodilator. Notable limitations
include inadequate potency, slow onset and offset of action, multiple receptor
function, safety concerns and, importantly, restricted/ineffective titration, which
results in clinically significant hemodynamic and cardiovascular perturbations.

Recently, the ultra short-acting intravenous dihydropyridine calcium-channel blocker
clevidipine (Cleviprex, The Medicines Company) was approved for management of BP in
critical care settings.

Clevidipine's pharmacology lends itself to acute management of BP in a broad critical
care setting in both surgical and nonsurgical patients. In the current study, the
investigators propose to further characterize the hemodynamic effect of CLV in the pre
and post-operative management of BP in patients with aortic aneurysm/dissection.

4. Design & Procedures Eligible patients will be approached to participate in the study by
the Intensive Care Unit (ICU) attending and/or by a cardiothoracic
surgical/anesthesiology fellow or a cardiac research nurse. All aspects of clinical
management and monitoring will be according to standard practice that includes:

- ECG

- Oxymetry

- Temperature

- Invasive arterial blood pressure

- Recording of routine laboratory results

- Imaging studies including CT/MRI (A)/ Echocardiography

- Pulmonary artery catheter (postoperative patients)

- Mechanical ventilation (postoperative patients)

- According to established protocol for acute intravenous management of arterial
blood pressure in these patients, an upper and lower threshold of systolic blood
pressure will be prescribed by the attending physician (the range being (100 mmHg
-120 mm Hg SBP).

Hemodynamic data will be collected continuously via a bedside laptop as well as pertinent
clinical data and information about efficacy and safety will be recorded.

• Subjective evaluation of efficacy of CLV (questionnaire format to be completed by the
critical care team)