Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Peacock WF

PROVIDER: S-EPMC3219031 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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

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

Critical care (London, England) 20110627 3

<h4>Introduction</h4>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.<h4>Methods</h4>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 endpo ...[more]

PMID: 21707983

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Project description:ObjectiveTo 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).DesignSecondary analysis of the multicentre prospective, randomised CLUE trial.Setting13 academic emergency departments in the USA.ParticipantsEligible 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.InterventionsMedications 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 measurePercentage of participants achieving a predefined target SBP range (TR) defined as an SBP within ±20 mm Hg as established by the treating physician.ResultsOf 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).ConclusionsIn 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 registrationNCT00765648, clinicaltrials.gov.

Project description:ObjectiveTo compare the effectiveness of amoxicillin-clavulanate versus amoxicillin for adults diagnosed with acute sinusitis (AS). A secondary objective compared antibiotic effectiveness in patients meeting risk criteria for treatment failure.MethodsA retrospective cohort study of adults diagnosed with AS prescribed amoxicillin ± clavulanate within Veterans Affairs emergency departments from 2012-2019 was conducted. The primary outcome was sinusitis-related return visits for amoxicillin versus amoxicillin-clavulanate. Secondary outcomes included 30-day infectious complications, gastrointestinal-related adverse events (AEs), and hospitalizations. Propensity-score matching and logistic regression models adjusted for potential confounders.ResultsA total of 89,627 AS patient visits were identified: 18,576 prescribed amoxicillin and 71,051 amoxicillin-clavulanate. Most patients were male (75,604; 84.4%) and afebrile (80,624; 91.7%). The propensity score-matched cohort comprised 17,929 amoxicillin and 42,294 amoxicillin-clavulanate patient visits. There was no difference in sinusitis-related return visits between amoxicillin (4.9%) and amoxicillin-clavulanate (5.1%) (adjusted odds ratio [OR], 0.96; 95% confidence interval [CI], 0.88, 1.04; P = 0.317). Infectious complications (amoxicillin [0.3%] vs amoxicillin-clavulanate [0.4%]); (adjusted OR, 0.78; 95% CI, 0.57, 1.07; P = 0.124) and hospitalization (amoxicillin [2.0%] vs amoxicillin-clavulanate [2.4%]); (adjusted OR, 0.92; 95% CI, 0.81, 1.04; P = 0.173) were not different. Gastrointestinal-related AEs were lower with amoxicillin (0.5%) relative to amoxicillin-clavulanate (0.7%); (adjusted OR, 0.67; 95% CI, 0.53, 0.86; P = 0.002). Comorbidity was the only guideline-recommended risk factor that was a significant predictor of infectious complications with respect to treatment (amoxicillin vs amoxicillin-clavulanate, OR, 0.63; 95% CI, 0.40 to 0.94; P = 0.022).ConclusionAmoxicillin demonstrated similar efficacy to amoxicillin-clavulanate for AS with fewer gastrointestinal-related AEs. Amoxicillin is a viable option in adults with AS meeting criteria for antibiotic therapy.

Project description:ImportanceMaternal emergency department (ED) use before or during pregnancy is associated with worse obstetrical outcomes, for reasons including preexisting medical conditions and challenges in accessing health care. It is not known whether maternal prepregnancy ED use is associated with higher use of the ED by their infant.ObjectiveTo study the association between maternal prepregnancy ED use and risk of infant ED use in the first year of life.Design, setting, and participantsThis population-based cohort study included all singleton livebirths in all of Ontario, Canada, from June 2003 to January 2020.ExposuresAny maternal ED encounter within 90 days preceding the start of the index pregnancy.Main outcomes and measuresAny infant ED visit up to 365 days after the index birth hospitalization discharge date. Relative risks (RR) and absolute risk differences (ARD) were adjusted for maternal age, income, rural residence, immigrant status, parity, having a primary care clinician, and number of prepregnancy comorbidities.ResultsThere were 2 088 111 singleton livebirths; the mean (SD) maternal age was 29.5 (5.4) years, 208 356 (10.0%) were rural dwelling, and 487 773 (23.4%) had 3 or more comorbidities. Among singleton livebirths, 206 539 mothers (9.9%) had an ED visit within 90 days before the index pregnancy. ED use in the first year of life was higher among infants whose mother had visited the ED before pregnancy (570 per 1000) vs those whose mother had not (388 per 1000) (RR, 1.19 [95% CI, 1.18-1.20]; ARD, 91.1 per 1000 [95% CI, 88.6-93.6 per 1000]). Compared with mothers without a prepregnancy ED visit, the RR of infant ED use in the first year was 1.19 (95% CI, 1.18-1.20) if its mother had 1 prepregnancy ED visit, 1.18 (95% CI, 1.17-1.20) following 2 visits, and 1.22 (95% CI, 1.20-1.23) after at least 3 maternal visits. A low-acuity maternal prepregnancy ED visit was associated with an adjusted odds ratio (aOR) of 5.52 (95% CI, 5.16-5.90) for a low-acuity infant ED visit, which was numerically higher than the pairing of a high-acuity ED use between mother and infant (aOR, 1.43, 95% CI, 1.38-1.49).Conclusions and relevanceIn this cohort study of singleton livebirths, prepregnancy maternal ED use was associated with a higher rate of ED use by the infant in the first year of life, especially for low-acuity ED use. This study's results may suggest a useful trigger for health system interventions aimed at reducing some ED use in infancy.

Project description:IntroductionAlcohol use disorders (AUD) place a significant burden on individuals and society. The emergency department (ED) offers a unique opportunity to address AUD with brief screening tools and early intervention. We undertook a systematic review of the effectiveness of ED brief interventions for patients identified through screening who are at risk for AUD, and the effectiveness of these interventions at reducing alcohol intake and preventing alcohol-related injuries.MethodsWe conducted systematic electronic database searches to include randomized controlled trials of AUD screening, brief intervention, referral, and treatment (SBIRT), from January 1966 to April 2016. Two authors graded and abstracted data from each included paper.ResultsWe found 35 articles that had direct relevance to the ED with enrolled patients ranging from 12 to 70 years of age. Multiple alcohol screening tools were used to identify patients at risk for AUD. Brief intervention (BI) and brief motivational intervention (BMI) strategies were compared to a control intervention or usual care. Thirteen studies enrolling a total of 5,261 participants reported significant differences between control and intervention groups in their main alcohol-outcome criteria of number of drink days and number of units per drink day. Sixteen studies showed a reduction of alcohol consumption in both the control and intervention groups; of those, seven studies did not identify a significant intervention effect for the main outcome criteria, but nine observed some significant differences between BI and control conditions for specific subgroups (i.e., adolescents and adolescents with prior history of drinking and driving; women 22 years old or younger; low or moderate drinkers); or secondary outcome criteria (e.g. reduction in driving while intoxicated).ConclusionModerate-quality evidence of targeted use of BI/BMI in the ED showed a small reduction in alcohol use in low or moderate drinkers, a reduction in the negative consequences of use (such as injury), and a decline in ED repeat visits for adults and children 12 years of age and older. BI delivered in the ED appears to have a short-term effect in reducing at-risk drinking.

Dataset Information

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

Publications

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

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