Phase 2
Completed N=30
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
Source: ClinicalTrials.gov NCT00799604 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Jun 2014
Primary outcomePrimary: The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). — -18.8; -37.0; -15.8 mm Hg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). |
-18.8; -37.0; -15.8 | — |
| PRIMARY The Mean Maximum Percent Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). |
-11.89; -22.10; -8.91 | — |
| SECONDARY The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). |
0; 0; 0 | — |
| SECONDARY The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia). |
0.9; 0.8; 1.0; 1.3; 1.1; NA | — |
| SECONDARY The Mean Percent Change in Systolic Blood Pressure From Baseline Over Time During the First 15 Minutes Following First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). |
0.96; -0.10; 0.18; 2.79; -2.41; -1.59 | — |
| SECONDARY The Median Time to 50%, and, When Available, 90% Recovery From Maximum SBP Effect Following the First Bolus Dose of Clevidipine for Patients Who Achieved the Endpoints (Treatment Period 1, Bolus 1 - Pre-anesthesia). |
1.8; 2.9; 2.5; 5.2; 6.8; NA | — |
| SECONDARY Change in Heart Rate After Bolus 1 (Pre-anesthesia). |
11.0; 3.1; 2.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00799604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.