CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department
1 Department of Emergency Medicine, The Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195 USA
2 The University of Texas Health Science Center at Houston and The University of Texas Medical Branch at Galveston, Galveston, Texas, 77555 USA
3 Division of Clinical Research and Associate Professor of Emergency Medicine, Cooper University Hospital, Camden, NJ, 08103-1489 USA
4 Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, 02114 USA
5 Department of Emergency Medicine, University of Kansas Hospital, Kansas City, KS, 66103-2918 USA
6 Division of Emergency Medicine, Duke University Medical Center, Durham, NC, 27710 USA
7 Wake Forest University School of Medicine, Winston Salem, NC, 27157 USA
8 University of California, Davis Medical Center, Sacramento, CA, 95817 USA
9 The Ohio State University, Columbus, OH 43210 USA. Currently affiliated with the Department of Emergency Medicine, Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157 USA
10 The Cleveland Clinic, 9500 Euclid Avenue,Cleveland OH, 44195 USA
11 Department of Emergency Medicine, University of Florida College of Medicine, Gainesville FL, 32610-0277 USA
12 Toledo Hospital, Toledo OH, 43606 USA
13 Department of Emergency Medicine, Wayne State University School of Medicine and the Cardiovascular Research Institute, Wayne State University (both in Detroit, MI), 48201-1998 USA
14 Department of Emergency Medicine, Wayne State University School of Medicine, Henry Ford Hospital, Detroit, Michigan, 48202-2689 USA
15 Department of Emergency Medicine, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH 44109 USA
Critical Care 2011, 15:R157 doi:10.1186/cc10289Published: 27 June 2011
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.
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.
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)
Patients treated with nicardipine are more likely to reach the physician-specified SBP target range within 30 minutes than those treated with labetalol.