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This study has been withdrawn prior to enrollment.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

October 14, 2011
February 7, 2013
December 2011
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01480531 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection
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)

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aorta Aneurysm
  • Dissection of Aorta
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01480531
Pro00030060
No
Duke University
Duke University
The Medicines Company
Principal Investigator: Manuel Fontes, MD Duke University
Duke University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP