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

February 7, 2013 updated by: Duke University

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)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The use of Clevidipine to maintain clinically acceptable blood pressure.
Time Frame: 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.
Begining 24 hours prior to surgery thru 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of hypotension
Time Frame: 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.
Begining 24 hours prior to surgery thru 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

The Medicines Company

Investigators

  • Principal Investigator: Manuel Fontes, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 14, 2011

First Submitted That Met QC Criteria

November 23, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00030060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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