Evaluation of IV Cardene(Nicardipine)and Labetalol Use in the Emergency Department
Information source: The Cleveland Clinic
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertensive Urgency
Intervention: Cardene I.V. (Drug); Labetalol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: The Cleveland Clinic Official(s) and/or principal investigator(s):
W. Frank Peacock, MD, Principal Investigator, Affiliation: Cleveland Clinic
Joseph Varon, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston
Overall contact:
Marilyn Borgman, BSN, RN, Phone: 216-445-6509, Email: borgmam@ccf.org
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: Variability in BP: Efficacy of BP control by comparing the AUC of BP-time curve between nicardipine and labetalolDetermine heart rate profile during treatment and during ED therapy Number of dose titrations for Cardene I.V. versus labetalol within 30 minutes ED time to disposition decision Treatment failure as defined by admission to the hospital or observation unit for BP management The percent of subjects requiring the use of IV rescue medications Transition time to oral medication Determine the pharmacoeconomic impact of the use of
Cardene I.V. compared to labetalol
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 years of age or older
- Systolic BP≥180 mm Hg on 2 consecutive readings(10 min apart)presenting in the ED
Exclusion Criteria:
- Use of any investigational drug within 1 month prior to ED
- Pregnant or breast-feeding females
- Contraindications or allergy to beta-blockers and calcium channel blockers (see FDA
approved labeling for Cardene I. V. and labetalol)
- Subjects with decompensated CHF or with a known LVEF <35%
- History of stroke within 30 days
- Known liver failure
- Suspected myocardial infarction
- Suspected aortic dissection
- Suspected cocaine overdose
- Concurrently receiving other I. V. hypertensive medications
Locations and Contacts
Marilyn Borgman, BSN, RN, Phone: 216-445-6509, Email: borgmam@ccf.org
Cleveland Clinic, Cleveland, Ohio 44122, United States; Recruiting
Marilyn Borgman, BSN, RN, Phone: 216-445-6509, Email: borgmam@ccf.org
Dianna L Bash, RN, Phone: 216-445-9664, Email: bashd@ccf.org
W Frank Peacock, MD, Principal Investigator
University of Texas Health Science Center, Houston, Texas, United States; Recruiting
Joseph Varon, MD, Phone: 713-669-1670, Email: jvaron@roamer.net
Additional Information
Starting date: October 2008
Ending date: January 2010
Last updated: April 6, 2009
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