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

Sponsor

Duke University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01480531

Collaborator

The Medicines Company (Industry)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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)

Condition or Disease	Intervention/Treatment	Phase
Aorta Aneurysm Dissection of Aorta	Drug: Clevidipine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Outcome Measures

Primary Outcome Measures

The use of Clevidipine to maintain clinically acceptable blood pressure. [Begining 24 hours prior to surgery thru 24 hours after surgery]
To determine the feasibility of Clevidipine use for rapidly achieving and maintaining individually specified patient BP target ranges (75 to 135 mm Hg) in the pre and postoperative periods of aortic aneurysm and dissection management.

Secondary Outcome Measures

The incidence of hypotension [Begining 24 hours prior to surgery thru 24 hours after surgery]
To determine the safety of Clevidipine use in the pre and postoperative periods of aneurysm and dissection management to prevent hypotension as defined by a systolic blood pressure of less than 75 mm Hg.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.