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Completed

NCT Number: NCT00765648

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

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.

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Key information

Conditions

Hypertensive Urgency Cardiovascular Diseases Disease Attributes Emergencies Hypertension Hypertensive Crisis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Clinic, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nicardipine intravenous

Drug

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 names: Nicardipine hydrochloride

labetalol

Drug

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.

Primary outcomes

  1. Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.

    Time frame: 30 minutes after initiation of therapy

    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.

Secondary outcomes

  1. Average Number of Dose Titrations Within 30 Minutes

    Time frame: 30 minutes

    Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group

  2. Emergency Department(ED)Time to Disposition Decision

    Time frame: 6 hours

    Median number of hours from hospital admission until Emergency Department(ED)disposition

  3. Treatment Failure

    Time frame: 6 hours

    Treatment failure is defined as admission to the hospital or observation unit for BP management

  4. Subjects Requiring the Use of Intravenous Rescue Medications

    Time frame: 6 hours

    The percent of subjects requiring the use of intravenous rescue medications

  5. Transition Time to Oral Medication

    Time frame: 6 hours

    The median transition time (in hours) to oral medication

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • EKR Therapeutics, Inc

Registry information

Official study 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

Acronym: CLUE

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 3, 2008
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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