Clinical trial NCT00765648: Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertensive Urgency
Keywords: hypertension
emergency department
Nicardipine
Labetalol
hypertensive emergency
hypertensive urgency
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: EKR Therapeutics, Inc
First posted: 2008-10-03
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.
timeFrame: 30 minutes after initiation of therapy
Secondary outcomes:
measure: Average Number of Dose Titrations Within 30 Minutes
timeFrame: 30 minutes
measure: Emergency Department(ED)Time to Disposition Decision
timeFrame: 6 hours
measure: Treatment Failure
timeFrame: 6 hours
measure: Subjects Requiring the Use of Intravenous Rescue Medications
timeFrame: 6 hours
measure: Transition Time to Oral Medication
timeFrame: 6 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: The Cleveland Clinic
name: W. Frank Peacock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Joseph Varon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varon J, Soto-Ruiz KM, Baumann BM, Borczuk P, Cannon CM, Chandra A, Cline DM, Diercks DB, Hiestand B, Hsu A, Jois-Bilowich P, Kaminski B, Levy P, Nowak RM, Schrock JW, Peacock WF. The management of acute hypertension in patients with renal dysfunction: labetalol or nicardipine? Postgrad Med. 2014 Jul;126(4):124-30. doi: 10.3810/pgm.2014.07.2790.
citation: Cannon CM, Levy P, Baumann BM, Borczuk P, Chandra A, Cline DM, Diercks DB, Hiestand B, Hsu A, Jois P, Kaminski B, Nowak RM, Schrock JW, Varon J, Peacock WF. Intravenous nicardipine and labetalol use in hypertensive patients with signs or symptoms suggestive of end-organ damage in the emergency department: a subgroup analysis of the CLUE trial. BMJ Open. 2013 Mar 26;3(3):e002338. doi: 10.1136/bmjopen-2012-002338.
citation: Peacock WF, Varon J, Baumann BM, Borczuk P, Cannon CM, Chandra A, Cline DM, Diercks D, Hiestand B, Hsu A, Jois-Bilowich P, Kaminski B, Levy P, Nowak RM, Schrock JW. CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department. Crit Care. 2011;15(3):R157. doi: 10.1186/cc10289. Epub 2011 Jun 27.