The purpose of this study was to determine the safety of clevidipine for treating severely elevated blood pressure, defined as systolic (SBP) \>180 mmHg and/or diastolic blood pressure (DBP) \>115 mmHg assessed on 2 successive occasions 15 minutes apart at baseline, in patients with or without major organ injury, particularly with respect to controlled dose adjustment to desired effect and prolonged continuous infusion. Enrollment of patients into the study was to continue until the target goal of 100 patients with at least 18 hours of continuous clevidipine treatment, including a minimum of 50 patients with acute or chronic end-organ injury, was met.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
131
Clevidipine was required to be administered continuously for a minimum of 18 hours and a maximum of 96 hours and was not to exceed a rate of 32.0 mg/h at any time. Use of an additional or alternative intravenous antihypertensive agent was allowed if the blood pressure target range was not achieved or maintained. If transition to an oral antihypertensive agent is required, then approximately 1 hour prior to the anticipated cessation of clevidipine infusion, but no less than at the 18-hour time point, an oral antihypertensive agent was allowed to be administered as clevidipine was down-titrated or terminated as needed in order to achieve the desired blood pressure level..
Jackson Hospital
Montgomery, Alabama, United States
VA Medical Center W. LA
Los Angeles, California, United States
The George Washington University Medical Center
Washington D.C., District of Columbia, United States
Louisiana State University Medical Center/Charity Hospital
New Orleans, Louisiana, United States
Critical Care Research Center at Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Good Samaritan Hospital
Baltimore, Maryland, United States
Duke University Medical Center
Durham, North Carolina, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
The Cleveland Clinic
Cleveland, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
...and 4 more locations
Percentage of patients in whom SBP falls below the lower limit of the patient-specific, pre-determined blood pressure target range at the initial dose (2.0 mg/h)
Time frame: Study drug initiation through the first 3 minutes of the infusion
Percentage of patients who reach the prespecified target SBP range
Time frame: Within 30 minutes of the initiation of the infusion
Time to attainment of the 30-minute SBP target range
Time frame: During the 30-minute period from initiation of infusion
Change in heart rate
Time frame: During the 30-minute period from initiation of infusion
Mean and median dose of clevidipine during the treatment period
Time frame: Treatment period is from initiation of infusion until study drug termination (minimum of 18 hours up to a maximum of 96 hours)
Proportion of patients transitioning to oral antihypertensive therapy
Time frame: Within 6 hours of stopping study drug infusion
Safety of clevidipine infusion for 18 hours or longer
Time frame: Treatment period is from initiation of infusion until study drug termination (minimum of 18 hours up to a maximum of 96 hours)
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