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

Primary Purpose

Hypertensive Urgency

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
nicardipine intravenous
Labetalol
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Urgency focused on measuring hypertension, emergency department, Nicardipine, Labetalol, hypertensive emergency, hypertensive urgency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic
  • University of Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

nicardipine intravenous

Labetalol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Average Number of Dose Titrations Within 30 Minutes
Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group
Emergency Department(ED)Time to Disposition Decision
Median number of hours from hospital admission until Emergency Department(ED)disposition
Treatment Failure
Treatment failure is defined as admission to the hospital or observation unit for BP management
Subjects Requiring the Use of Intravenous Rescue Medications
The percent of subjects requiring the use of intravenous rescue medications
Transition Time to Oral Medication
The median transition time (in hours) to oral medication

Full Information

First Posted
October 1, 2008
Last Updated
December 11, 2014
Sponsor
The Cleveland Clinic
Collaborators
EKR Therapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00765648
Brief Title
Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
EKR Therapeutics, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Urgency
Keywords
hypertension, emergency department, Nicardipine, Labetalol, hypertensive emergency, hypertensive urgency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
nicardipine intravenous
Arm Title
2
Arm Type
Active Comparator
Arm Description
Labetalol
Intervention Type
Drug
Intervention Name(s)
nicardipine intravenous
Other Intervention Name(s)
Nicardipine hydrochloride
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Labetalol
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.
Description
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.
Time Frame
30 minutes after initiation of therapy
Secondary Outcome Measure Information:
Title
Average Number of Dose Titrations Within 30 Minutes
Description
Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group
Time Frame
30 minutes
Title
Emergency Department(ED)Time to Disposition Decision
Description
Median number of hours from hospital admission until Emergency Department(ED)disposition
Time Frame
6 hours
Title
Treatment Failure
Description
Treatment failure is defined as admission to the hospital or observation unit for BP management
Time Frame
6 hours
Title
Subjects Requiring the Use of Intravenous Rescue Medications
Description
The percent of subjects requiring the use of intravenous rescue medications
Time Frame
6 hours
Title
Transition Time to Oral Medication
Description
The median transition time (in hours) to oral medication
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Frank Peacock, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Varon, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25141250
Citation
Varon J, Soto-Ruiz KM, Baumann BM, Borczuk P, Cannon CM, Chandra A, Cline DM, Diercks DB, Hiestand B, Hsu A, Jois-Bilowich P, Kaminski B, Levy P, Nowak RM, Schrock JW, Peacock WF. The management of acute hypertension in patients with renal dysfunction: labetalol or nicardipine? Postgrad Med. 2014 Jul;126(4):124-30. doi: 10.3810/pgm.2014.07.2790.
Results Reference
derived
PubMed Identifier
23535700
Citation
Cannon CM, Levy P, Baumann BM, Borczuk P, Chandra A, Cline DM, Diercks DB, Hiestand B, Hsu A, Jois P, Kaminski B, Nowak RM, Schrock JW, Varon J, Peacock WF. Intravenous nicardipine and labetalol use in hypertensive patients with signs or symptoms suggestive of end-organ damage in the emergency department: a subgroup analysis of the CLUE trial. BMJ Open. 2013 Mar 26;3(3):e002338. doi: 10.1136/bmjopen-2012-002338.
Results Reference
derived
PubMed Identifier
21707983
Citation
Peacock WF, Varon J, Baumann BM, Borczuk P, Cannon CM, Chandra A, Cline DM, Diercks D, Hiestand B, Hsu A, Jois-Bilowich P, Kaminski B, Levy P, Nowak RM, Schrock JW. CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department. Crit Care. 2011;15(3):R157. doi: 10.1186/cc10289. Epub 2011 Jun 27.
Results Reference
derived

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

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