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

This study has been withdrawn prior to enrollment.
(We elected to stop this study due to our inability to recruit suitable subjects.)
Sponsor:
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01480531
First received: October 14, 2011
Last updated: February 7, 2013
Last verified: January 2013
  Purpose

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)


Condition Intervention
Aorta Aneurysm
Dissection of Aorta
Drug: Clevidipine

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection.

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • The use of Clevidipine to maintain clinically acceptable blood pressure. [ Time Frame: Begining 24 hours prior to surgery thru 24 hours after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Begining 24 hours prior to surgery thru 24 hours after surgery ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 0
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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)

    Other Name: Cleviprex
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients (age 18-80 years)
  2. Able to provide written consent
  3. Type I and Type II (Type A) aortic dissection or unstable chronic aortic aneurysm
  4. 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:

  1. Unstable emergent dissections
  2. Evidence of end-organ dysfunction (ischemia of spinal cord, bowel, myocardium or renal)
  3. Active bleeding
  4. Allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis
  5. Women who are pregnant
  6. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480531

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
The Medicines Company
Investigators
Principal Investigator: Manuel Fontes, MD Duke University
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01480531     History of Changes
Other Study ID Numbers: Pro00030060
Study First Received: October 14, 2011
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
aorta
aneurysm
dissection

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 29, 2014