Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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 cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine after bolus administration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Medicines Company
• Treatments: Clevidipine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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