Evaluation of IV 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.
|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 I.V. Versus Labetalol for Management of Hypertensive Emergencies in the Emergency Department Setting|
- Percentage of subjects achieving a pre-defined target systolic BP range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator. [ Time Frame: 30 minutes after initiation of therapy ] [ Designated as safety issue: Yes ]
- Variability in BP: Efficacy of BP control by comparing the AUC of BP-time curve between nicardipine and labetalol [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Determine heart rate profile during treatment and during ED therapy [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Number of dose titrations for Cardene I.V. versus labetalol within 30 minutes [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- ED time to disposition decision [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Treatment failure as defined by admission to the hospital or observation unit for BP management [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- The percent of subjects requiring the use of IV rescue medications [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Transition time to oral medication [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Determine the pharmacoeconomic impact of the use of Cardene I.V. compared to labetalol [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
|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: Cardene I.V.
Cardene I.V.: 5 mg/h titrated every 5 minutes by 2.5 mg/h until TSBPR is reached or maximum dose of 15 mg/hour is achieved.Following achievement of TSBPR the infusion rate should be decreased to 3 mg/hr
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 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.
|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|