Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department

Phase 4

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

18 years of age or older
Systolic blood pressure ≥180 mm Hg on 2 consecutive readings(10 minutes apart)presenting in the emergency department (ED)

Exclusion Criteria

Use of any investigational drug within 1 month prior to emergency department (ED)
Pregnant or breast-feeding females
Contraindications or allergy to beta-blockers and calcium channel blockers (see FDA approved labeling for nicardipine intravenous and labetalol)
Subjects with decompensated congestive heart failure (CHF) or with a known left ventricular ejection fraction (LVEF) <35%
History of stroke within 30 days
Known liver failure
Suspected myocardial infarction
Suspected aortic dissection
Suspected cocaine overdose
Concurrently receiving other intravenous (I.V.) hypertensive medications

Arm && Interventions

Group	Intervention	Description
1	nicardipine intravenous	nicardipine intravenous
2	Labetalol	Labetalol

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.	30 minutes after initiation of therapy	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.

Secondary Outcome Measures

Name	Time	Method
Average Number of Dose Titrations Within 30 Minutes	30 minutes	Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group
Emergency Department(ED)Time to Disposition Decision	6 hours	Median number of hours from hospital admission until Emergency Department(ED)disposition
Treatment Failure	6 hours	Treatment failure is defined as admission to the hospital or observation unit for BP management
Transition Time to Oral Medication	6 hours	The median transition time (in hours) to oral medication
Subjects Requiring the Use of Intravenous Rescue Medications	6 hours	The percent of subjects requiring the use of intravenous rescue medications