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

Condition(s) targeted: Hypertensive Urgency

Intervention: nicardipine intravenous (Drug); Labetalol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: The Cleveland Clinic

Official(s) and/or principal investigator(s):
W. Frank Peacock, MD, Principal Investigator, Affiliation: The Cleveland Clinic
Joseph Varon, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.

Secondary outcome:

Average Number of Dose Titrations Within 30 Minutes

Emergency Department(ED)Time to Disposition Decision

Treatment Failure

Subjects Requiring the Use of Intravenous Rescue Medications

Transition Time to Oral Medication

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Cleveland Clinic, Cleveland, Ohio 44122, United States

University of Texas Health Science Center, Houston, Texas, United States

Starting date: October 2008
Last updated: December 11, 2014