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

Hypertensive Urgency Clinical Trial

— CLUE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765648
• Other study ID #: 2008-001
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2008
• Last updated: December 11, 2014
• Start date: October 2008
• Est. completion date: January 2010

Study information

• Verified date: July 2011
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

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

Related Conditions & MeSH terms

• Emergencies
• Hypertensive Urgency

Intervention

Drug:
• nicardipine intravenous
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
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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	EKR Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Emergency Department(ED)Time to Disposition Decision	Median number of hours from hospital admission until Emergency Department(ED)disposition	6 hours	No
Secondary	Treatment Failure	Treatment failure is defined as admission to the hospital or observation unit for BP management	6 hours	No
Secondary	Subjects Requiring the Use of Intravenous Rescue Medications	The percent of subjects requiring the use of intravenous rescue medications	6 hours	No
Secondary	Transition Time to Oral Medication	The median transition time (in hours) to oral medication	6 hours	No