Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department (CLUE)
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.
Drug: nicardipine intravenous
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. [ Time Frame: 30 minutes after initiation of therapy ] [ Designated as safety issue: No ]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.
- Average Number of Dose Titrations Within 30 Minutes [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group
- Emergency Department(ED)Time to Disposition Decision [ Time Frame: 6 hours ] [ Designated as safety issue: No ]Median number of hours from hospital admission until Emergency Department(ED)disposition
- Treatment Failure [ Time Frame: 6 hours ] [ Designated as safety issue: No ]Treatment failure is defined as admission to the hospital or observation unit for BP management
- Subjects Requiring the Use of Intravenous Rescue Medications [ Time Frame: 6 hours ] [ Designated as safety issue: No ]The percent of subjects requiring the use of intravenous rescue medications
- Transition Time to Oral Medication [ Time Frame: 6 hours ] [ Designated as safety issue: No ]The median transition time (in hours) to oral medication
|Study Start Date:||October 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
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
Other Name: Nicardipine hydrochloride
Active Comparator: 2
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765648
|United States, Ohio|
|Cleveland, Ohio, United States, 44122|
|United States, Texas|
|University of Texas Health Science Center|
|Houston, Texas, United States|
|Principal Investigator:||W. Frank Peacock, MD||The Cleveland Clinic|
|Principal Investigator:||Joseph Varon, MD||The University of Texas Health Science Center, Houston|