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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase IV, Randomized Trial to Determine the Efficacy and Safety of Cardene Intravenous (I.V.) Versus Labetalol for Management of Hypertensive Emergencies in the Emergency Department Setting

Conditions
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Hypertensive Urgency

Intervention / Treatment
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* Drug: nicardipine intravenous
* Drug: Labetalol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>nicardipine intravenous | Drug: nicardipine intravenous<br>* 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<br>* Other names: Nicardipine hydrochloride;|
| Active Comparator: 2<br>Labetalol | Drug: Labetalol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes after initiation of therapy | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, emergency department, Nicardipine, Labetalol, hypertensive emergency, hypertensive urgency