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CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department

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Material Information

Title:
CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department
Physical Description:
Mixed Material
Language:
English
Creator:
Peacock, W. Frank
Varon, Joseph
Baumann, Brigitte M.
Borczuk, Pierre
Cannon, Chad M.
Chandra, Abhinav
Cline, David M.
Diercks, Deborah
Publisher:
Bio-Med Central (Critical Care)
Publication Date:

Notes

Abstract:
Introduction: Our purpose was to compare the safety and efficacy of food and drug administration (FDA) recommended dosing of IV nicardipine versus IV labetalol for the management of acute hypertension. Methods: Multicenter randomized clinical trial. Eligible patients had 2 systolic blood pressure (SBP) measures ≥180 mmHg and no contraindications to nicardipine or labetalol. Before randomization, the physician specified a target SBP ± 20 mmHg (the target range: TR). The primary endpoint was the percent of subjects meeting TR during the initial 30 minutes of treatment. Results: Of 226 randomized patients, 110 received nicardipine and 116 labetalol. End organ damage preceded treatment in 143 (63.3%); 71 nicardipine and 72 labetalol patients. Median initial SBP was 212.5 (IQR 197, 230) and 212 mmHg (IQR 200,225) for nicardipine and labetalol patients (P = 0.68), respectively. Within 30 minutes, nicardipine patients more often reached TR than labetalol (91.7 vs. 82.5%, P = 0.039). Of 6 BP measures (taken every 5 minutes) during the study period, nicardipine patients had higher rates of five and six instances within TR than labetalol (47.3% vs. 32.8%, P = 0.026). Rescue medication need did not differ between nicardipine and labetalol (15.5 vs. 22.4%, P = 0.183). Labetalol patients had slower heart rates at all time points (P < 0.01). Multivariable modeling showed nicardipine patients were more likely in TR than labetalol patients at 30 minutes (OR 2.73, P = 0.028; C stat for model = 0.72) Conclusions: Patients treated with nicardipine are more likely to reach the physician-specified SBP target range within 30 minutes than those treated with labetalol. Trial registration: ClinicalTrials.gov: NCT00765648
General Note:
Peacock et al. Critical Care 2011, 15:R157 http://ccforum.com/content/15/3/R157; Pages 1-8
General Note:
doi:10.1186/cc10289 Cite this article as: Peacock et al.: CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department. Critical Care 2011 15:R157.

Record Information

Source Institution:
University of Florida
Holding Location:
University of Florida
Rights Management:
All rights reserved by the source institution.
Resource Identifier:
oclc -
System ID:
AA00018761:00001

Material Information

Title:
CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department
Physical Description:
Mixed Material
Language:
English
Creator:
Peacock, W. Frank
Varon, Joseph
Baumann, Brigitte M.
Borczuk, Pierre
Cannon, Chad M.
Chandra, Abhinav
Cline, David M.
Diercks, Deborah
Publisher:
Bio-Med Central (Critical Care)
Publication Date:

Notes

Abstract:
Introduction: Our purpose was to compare the safety and efficacy of food and drug administration (FDA) recommended dosing of IV nicardipine versus IV labetalol for the management of acute hypertension. Methods: Multicenter randomized clinical trial. Eligible patients had 2 systolic blood pressure (SBP) measures ≥180 mmHg and no contraindications to nicardipine or labetalol. Before randomization, the physician specified a target SBP ± 20 mmHg (the target range: TR). The primary endpoint was the percent of subjects meeting TR during the initial 30 minutes of treatment. Results: Of 226 randomized patients, 110 received nicardipine and 116 labetalol. End organ damage preceded treatment in 143 (63.3%); 71 nicardipine and 72 labetalol patients. Median initial SBP was 212.5 (IQR 197, 230) and 212 mmHg (IQR 200,225) for nicardipine and labetalol patients (P = 0.68), respectively. Within 30 minutes, nicardipine patients more often reached TR than labetalol (91.7 vs. 82.5%, P = 0.039). Of 6 BP measures (taken every 5 minutes) during the study period, nicardipine patients had higher rates of five and six instances within TR than labetalol (47.3% vs. 32.8%, P = 0.026). Rescue medication need did not differ between nicardipine and labetalol (15.5 vs. 22.4%, P = 0.183). Labetalol patients had slower heart rates at all time points (P < 0.01). Multivariable modeling showed nicardipine patients were more likely in TR than labetalol patients at 30 minutes (OR 2.73, P = 0.028; C stat for model = 0.72) Conclusions: Patients treated with nicardipine are more likely to reach the physician-specified SBP target range within 30 minutes than those treated with labetalol. Trial registration: ClinicalTrials.gov: NCT00765648
General Note:
Peacock et al. Critical Care 2011, 15:R157 http://ccforum.com/content/15/3/R157; Pages 1-8
General Note:
doi:10.1186/cc10289 Cite this article as: Peacock et al.: CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department. Critical Care 2011 15:R157.

Record Information

Source Institution:
University of Florida
Holding Location:
University of Florida
Rights Management:
All rights reserved by the source institution.
Resource Identifier:
oclc -
System ID:
AA00018761:00001