Dataset Information

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.

ABSTRACT:

Objective

To compare the efficacy of Food and Drug Administration recommended dosing of nicardipine versus labetalol for the management of hypertensive patients with signs and/or symptoms (S/S) suggestive of end-organ damage (EOD).

Design

Secondary analysis of the multicentre prospective, randomised CLUE trial.

Setting

13 academic emergency departments in the USA.

Participants

Eligible patients had two systolic blood pressure (SBP) measures ?180 mm Hg at least 10 min apart, no contraindications to nicardipine or labetalol and predefined S/S suggestive of EOD on arrival.

Interventions

Medications were administered by continuous infusion (nicardipine) or repeat intravenous bolus (labetalol) for a study period of 30 min or until a specified target SBP ±20 mm Hg was achieved.

Primary outcome measure

Percentage of participants achieving a predefined target SBP range (TR) defined as an SBP within ±20 mm Hg as established by the treating physician.

Results

Of the 141 eligible patients, 49.6% received nicardipine, 51.7% were women and 81.6% were black. Mean age was 52.2±13.9 years. Median initial SBP did not differ in the nicardipine (210.5 (IQR 197-226) mm Hg) and labetalol (210 (200-226) mm Hg) groups (p=0.862). Nicardipine patients were more likely to have a history of diabetes (41.4% vs 25.7%, p=0.05) but there were no other historical, demographic or laboratory differences between groups. Within 30 min, nicardipine patients more often reached the target SBP range than those receiving labetalol (91.4% vs 76.1%, difference=15.3% (95% CI 3.5% to 27.3%); p=0.01). On multivariable modelling with adjustment for gender and clinical site, nicardipine patients were more likely to be in TR by 30 min than patients receiving labetalol (OR 3.65, 95% CI 1.31 to 10.18, C statistic=0.72).

Conclusions

In the setting of hypertension with suspected EOD, patients treated with nicardipine are more likely to reach prespecified SBP targets within 30 min than patients receiving labetalol.

Clinical trial registration

NCT00765648, clinicaltrials.gov.

SUBMITTER: Cannon CM

PROVIDER: S-EPMC3612758 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Cannon Chad M CM Levy Phillip P Baumann Brigitte M BM Borczuk Pierre P Chandra Abhinav A Cline David M DM Diercks Deborah B DB Hiestand Brian B Hsu Amy A Jois Preeti P Kaminski Brian B Nowak Richard M RM Schrock Jon W JW Varon Joseph J Peacock W Frank WF

BMJ open 20130326 3

<h4>Objective</h4>To compare the efficacy of Food and Drug Administration recommended dosing of nicardipine versus labetalol for the management of hypertensive patients with signs and/or symptoms (S/S) suggestive of end-organ damage (EOD).<h4>Design</h4>Secondary analysis of the multicentre prospective, randomised CLUE trial.<h4>Setting</h4>13 academic emergency departments in the USA.<h4>Participants</h4>Eligible patients had two systolic blood pressure (SBP) measures ≥180 mm Hg at least 10 min ...[more]

PMID: 23535700

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Project description:IntroductionChildren often present to the emergency department (ED) with minor conditions such as fever and have persistently abnormal vital signs. We hypothesized that a significant portion of children discharged from the ED would have abnormal vital signs and that those discharged with abnormal vital signs would experience very few adverse events.MethodsWe performed a retrospective chart review encompassing a 44-month period of all pediatric patients (aged two months to 17 years) who were discharged from the ED with an abnormal pulse rate, respiratory rate, temperature, or oxygen saturation. We used a local quality assurance database to identify pre-defined adverse events after discharge in this population. Our primary aim was to determine the proportion of children discharged with abnormal vital signs and the frequency and nature of adverse events. Additionally, we performed a sub-analysis comparing the rate of adverse events in children discharged with normal vs. abnormal vital signs, as well as a standardized review of the nature of each adverse event.ResultsOf 33,185 children discharged during the study period, 5,540 (17%) of these patients had at least one abnormal vital sign. There were 24/5,540 (0.43%) adverse events in the children with at least one abnormal vital sign vs. 47/27,645 (0.17%) adverse events in the children with normal vital signs [relative risk = 2.5 (95% confidence interval, 1.6 to 2.4)].However, upon review of each adverse event we found only one case that was related to the index visit, was potentially preventable by a 23-hour hospital observation, and caused permanent disability.ConclusionIn our study population, 17% of the children were discharged with at least one abnormal vital sign, and there were very few adverse (0.43%) events associated with this practice. Heart rate was the most common abnormal vital sign leading to an adverse event. Severe adverse events that were potentially related to the abnormal vital sign(s) were exceedingly rare. Additional research is needed in broader populations to better determine the rate of adverse events and possible methods of avoiding them.

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Dataset Information

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.

Objective

Design

Setting

Participants

Interventions

Primary outcome measure

Results

Conclusions

Clinical trial registration

Publications

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.

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