Status:
COMPLETED
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
Lead Sponsor:
The Medicines Company
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardi...
Detailed Description
Study participants were screened up to 14 days prior to their elective cardiac surgery. For the purpose of this study, hypertension was defined as systolic blood pressure (SBP) ≥140 mm Hg immediately ...
Eligibility Criteria
Inclusion
- Require elective cardiac operation involving the use of cardiopulmonary bypass
- Age 18 years or older
- A history or hypertension and/or expected to require perioperative antihypertensive therapy in the opinion of the investigator
- Written informed consent
- Pre-anesthesia baseline SBP ≥140 mm Hg just prior to bolus, measured using an arterial line
Exclusion
- Receiving either intravenous vasopressor or intravenous vasodilatory therapy in the 72 hours prior to dosing
- Critical left main coronary artery stenosis
- Critical aortic valve (\<0.5 cm3) or mitral valve (\<1.0 cm3) stenosis
- Acute myocardial infarction within the prior 14 days
- Fully paced cardiac rhythm
- Known or suspected aortic dissection
- Requiring preoperative intra-aortic balloon pump counterpulsation therapy
- Contraindication to transesophageal echocardiography
- Positive pregnancy test or breast feeding
- Intolerance or allergy to calcium channel blockers
- Allergy to soybean oil or egg lecithin
- Any condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the patient from completing the study
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00799604
Start Date
November 1 2008
End Date
October 1 2009
Last Update
August 29 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital, Harvard Medical School
Boston, Massachusetts, United States, 02114
2
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104