The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol administered intravenously for the management of hypertension in the emergency department setting.
More than 3 million patients yearly receive an intravenous antihypertensive agent in the US. Despite this large number of critically ill patients treated annually, little research exists in the area of acute severe hypertension, specifically hypertensive emergency, a serious condition that contributes to morbidity and mortality. Two agents that are commonly used to treat acute hypertensive crisis include labetalol and nicardipine. Cardene may provide benefits in titration and has shown to have lower dosage adjustments compared to labetalol. Nicardipine has also shown a decreased need for additional antihypertensives when compared to labetalol in patients with stroke in a neurological ICU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
226
nicardipine intravenous 5 mg/hour titrated every 5 minutes by 2.5 mg/hour until target systolic blood pressure range (TSBPR) is reached or maximum dose of 15 mg/hour is achieved.Following achievement of target systolic blood pressure range the infusion rate should be decreased to 3 mg/hour
Labetalol: bolus therapy to start at 20 mg intravenous injection over 2 minutes, may repeat 20mg, 40mg or 80mg injections every 10 minutes until target systolic blood pressure range(TSBPR)is reached or a maximum of 300 mg is injected.
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas Health Science Center
Houston, Texas, United States
Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.
Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator.
Time frame: 30 minutes after initiation of therapy
Average Number of Dose Titrations Within 30 Minutes
Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group
Time frame: 30 minutes
Emergency Department(ED)Time to Disposition Decision
Median number of hours from hospital admission until Emergency Department(ED)disposition
Time frame: 6 hours
Treatment Failure
Treatment failure is defined as admission to the hospital or observation unit for BP management
Time frame: 6 hours
Subjects Requiring the Use of Intravenous Rescue Medications
The percent of subjects requiring the use of intravenous rescue medications
Time frame: 6 hours
Transition Time to Oral Medication
The median transition time (in hours) to oral medication
Time frame: 6 hours
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