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

NCT ID: NCT00799604

Last Updated: 2014-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-10-31

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

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 prior to initiation of study drug.

On the day of surgery, an IV bolus dose of clevidipine (Bolus 1 - pre-anesthesia) was administered to each eligible study participant during Treatment Period 1 to decrease BP before induction of general anesthesia. The dose (either 125 μg, 250 μg or 500 μg) given was based on the assigned cohort for each participant, listed in the 'Arms' section below.

At the discretion of the investigator, a second IV bolus dose of clevidipine (Bolus 2 - with anesthesia) could have been administered during Treatment Period 2 at either 125 μg, 250 μg or 500 μg, based upon the earlier observed response to Bolus 1. This dose was administered after the induction of anesthesia, to decrease BP prior to cannulation of the ascending aorta for initiation of cardiopulmonary bypass.

Assessment of safety was performed throughout Treatment Periods 1 and 2 with Adverse Events (AEs) followed 6 hours post final bolus dose and Serious Adverse Events (SAEs) followed 24 hours post final bolus dose.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

clevidipine

Patients were sequentially assigned to one of following three planned dose cohorts for Bolus 1 within the clevidipine arm:

• Cohort 1: clevidipine 250 µg (0.5 mL)
• Cohort 2: clevidipine 500 µg (1 mL)
• Cohort 3: clevidipine 125 µg (0.25 mL or 0.5 mL of a 1:1 solution)

Group Type: EXPERIMENTAL

clevidipine

Intervention Type: DRUG

Clevidipine (0.5mg/mL in 20% lipid emulsion) was administered as an IV bolus (\<5 sec) by rapid injection for Bolus 1 and for Bolus 2, if second bolus dose was administered, directly into a peripheral venous catheter followed by a normal saline flush (10mL).

Interventions

clevidipine

Clevidipine (0.5mg/mL in 20% lipid emulsion) was administered as an IV bolus (\<5 sec) by rapid injection for Bolus 1 and for Bolus 2, if second bolus dose was administered, directly into a peripheral venous catheter followed by a normal saline flush (10mL).

Intervention Type: DRUG

Other Intervention Names

clevidipine injectable emulsion; clevidipine emulsion; Cleviprex

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Medicines Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert T. Cheung, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Edwin G. Avery, IV, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital, Harvard Medical School

Boston, Massachusetts, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

TMC-CLV-08-02

Identifier Type: -

Identifier Source: org_study_id