Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial.

STUDY OBJECTIVE: Acute urticaria is a frequent presentation in emergency departments (EDs), urgent care centers, and other clinical arenas. Treatment options are limited if diphenhydramine is the only intravenous antihistamine offered because of its short duration of action and well-known adverse effects. We evaluate cetirizine injection, the first second-generation injectable antihistamine, for acute urticaria in this multicenter, randomized, noninferiority, phase 3 clinical trial. METHODS: Adult patients presenting to EDs and urgent care centers with acute urticaria requiring an intravenous antihistamine were randomized to either intravenous cetirizine 10 mg or intravenous diphenhydramine 50 mg. The primary endpoint was the 2-hour pruritus score change from baseline, with time spent in treatment center and rate of return to treatment centers as key secondary endpoints. Frequency of sedation and anticholinergic adverse effects were also recorded. RESULTS: Among 262 enrolled patients, the 2-hour pruritus score change from baseline for intravenous cetirizine was statistically noninferior to that for intravenous diphenhydramine (-1.6 versus -1.5; 95% confidence interval -0.1 to 0.3), and in favor of cetirizine. Treatment differences also favored cetirizine for mean time spent in treatment center (1.7 versus 2.1 hours; P=.005), return to treatment center (5.5% versus 14.1%; P=.02), lower change from baseline sedation score at 2 hours (0.1 versus 0.5; P=.03), and adverse event rate (3.9% versus 13.3%). CONCLUSION: Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.

Ecallantide for the acute treatment of angiotensin-converting enzyme inhibitor-induced angioedema: a multicenter, randomized, controlled trial.

STUDY OBJECTIVE: We compare the safety and efficacy of ecallantide with placebo in subjects undergoing assessment for acute angiotensin-converting enzyme inhibitor-induced angioedema (ACEIA) in an emergency department (ED). METHODS: This was a multicenter, phase 2, double-blind study with subjects randomized to receive a single subcutaneous dose of ecallantide (10, 30, or 60 mg) or placebo plus physician-directed conventional therapy. The primary endpoint was defined as meeting predetermined discharge eligibility criteria within 6 hours of study drug administration. Discharge criteria included improvement of edema, stable vital signs, absence of stridor, absence of dyspnea or use of accessory muscles during respiration, absence of drooling, and ability to drink without difficulty. RESULTS: An interim analysis showed that a high percentage of subjects met the primary endpoint, and the study was halted. Overall, 79 subjects were randomized and 76 had data for analysis. Most had mild (45%) or moderate (42%) ACEIA. The discharge eligibility endpoint was met by 72% of the placebo group and 85%, 89%, and 89% of the ecallantide 10-, 30-, and 60-mg groups, respectively. This difference in meeting discharge eligibility endpoint criteria between treatment groups was not statistically significant. The incidence of treatment-emergent adverse events was similar between placebo and active-treatment groups. CONCLUSION: The addition of ecallantide to standard therapy does not appear to improve angioedema compared with placebo in ED patients with ACEIA. Our data suggest that most ED patients presenting with mild to moderate ACEIA are likely to meet our discharge eligibility criteria within 6 hours of treatment, regardless of intervention. Further studies to assess the utility of ecallantide in patients with more severe angioedema may be useful. No new safety signals related to ecallantide administration were identified.

Headpulse measurement can reliably identify large-vessel occlusion stroke in prehospital suspected stroke patients: Results from the EPISODE-PS-COVID study.

BACKGROUND: Large-vessel occlusion (LVO) stroke represents one-third of acute ischemic stroke (AIS) in the United States but causes two-thirds of poststroke dependence and >90% of poststroke mortality. Prehospital LVO stroke detection permits efficient emergency medical systems (EMS) transport to an endovascular thrombectomy (EVT)-capable center. Our primary objective was to determine the feasibility of using a cranial accelerometry (CA) headset device for prehospital LVO stroke detection. Our secondary objective was development of an algorithm capable of distinguishing LVO stroke from other conditions. METHODS: We prospectively enrolled consecutive adult patients suspected of acute stroke from 11 study hospitals in four different U.S. geographical regions over a 21-month period. Patients received device placement by prehospital EMS personnel. Headset data were matched with clinical data following informed consent. LVO stroke diagnosis was determined by medical chart review. The device was trained using device data and Los Angeles Motor Scale (LAMS) examination components. A binary threshold was selected for comparison of device performance to LAMS scores. RESULTS: A total of 594 subjects were enrolled, including 183 subjects who received the second-generation device. Usable data were captured in 158 patients (86.3%). Study subjects were 53% female and 56% Black/African American, with median age 69 years. Twenty-six (16.4%) patients had LVO and 132 (83.6%) were not LVO (not-LVO AIS, 33; intracerebral hemorrhage, nine; stroke mimics, 90). COVID-19 testing and positivity rates (10.6%) were not different between groups. We found a sensitivity of 38.5% and specificity of 82.7% for LAMS ≥ 4 in detecting LVO stroke versus a sensitivity of 84.6% (p < 0.0015 for superiority) and specificity of 82.6% (p = 0.81 for superiority) for the device algorithm (CA + LAMS). CONCLUSIONS: Obtaining adequate recordings with a CA headset is highly feasible in the prehospital environment. Use of the device algorithm incorporating both CA and LAMS data for LVO detection resulted in significantly higher sensitivity without reduced specificity when compared to the use of LAMS alone.

Hepatitis C Virus Reflex Testing Protocol in an Emergency Department.

INTRODUCTION: Our aim was to measure hepatitis C virus (HCV) screening and linkage-to-care rates in an urban emergency department (ED) before and after implementing an HCV viral RNA (vRNA) reflex testing protocol within a HCV screening program for at-risk patients. Our hypothesis was that using a reflex testing protocol would increase HCV testing rates of at-risk patients in the ED, which would increase the linkage-to-care rate. METHODS: In August 2018, our institution implemented an automated, electronic health record-based HCV screening protocol in the ED for at-risk patients. In January 2019, we implemented an HCV vRNA reflex testing protocol (reflex testing) for all positive HCV antibody (Ab) tests that were initiated through the screening protocol. We compared completion rates of HCV vRNA testing and the rate of linkage to care for patients with positive HCV Ab test results before and after implementation of reflex testing (five months per study period). RESULTS: Prior to reflex testing implementation, 233/425 (55%) patients with a positive HCV Ab test had an HCV vRNA test performed, whereas 270/323 (84%) patients with a positive HCV Ab test result had vRNA testing after reflex testing implementation (odds ratio [OR], 4.2; 95% confidence interval (CI): 3.0-6.0; P < 0.001). Of the eligible patients with positive HCV Ab test results who could be linked to care, 45 (10.6%) were linked to care before HCV reflex implementation and 46 (14.2%) were linked to care with reflex testing (OR, 1.4; 95% CI: 0.9-2.2; P = 0.13). CONCLUSION: Implementing a reflex testing initiative into an HCV screening program in the ED can result in an increase of the percentage of patients who receive an HCV vRNA test after having had a positive HCV Ab. Hepatitis C virus vRNA reflex testing was not associated with a statistically significant increase in linkage-to-care rates for HCV Ab-positive patients; however, further studies are required.

Prehospital Tibial Intraosseous Drug Administration is Associated with Reduced Survival Following Out of Hospital Cardiac Arrest: A study for the CARES Surveillance Group.

BACKGROUND: Recent reports have questioned the efficacy of intraosseous (IO) drug administration for out-of-hospital cardiac arrest (OHCA) resuscitation. Our aim was to determine whether prehospital administration of resuscitative medications via the IO route was associated with lower rates of return of spontaneous circulation (ROSC) and survival to hospital discharge than peripheral intravenous (IV) infusion in the setting of OHCA. METHODS: We obtained data on all OHCA patients receiving prehospital IV or IO drug administration from the three most populous counties in Michigan over three years. Data was from the Michigan Cardiac Arrest Registry to Enhance Survival (CARES) database. The association between route of drug administration and outcomes was tested using a matched propensity score analysis. RESULTS: From a total of 10,626 OHCA patients, 6869 received parenteral drugs during their prehospital resuscitation (37.8% by IO) and were included in analysis. Unadjusted outcomes were lower in patients with IO vs. IV access: 18.3% vs. 23.8% for ROSC (p < 0.001), 3.2% vs. 7.6% for survival to hospital discharge (p < 0.001), and 2.0% vs. 5.8% for favorable neurological function (p < 0.001). After adjustment, IO route remained associated with lower odds of sustained ROSC (OR 0.72, 95% CI 0.63-0.81, p < 0.001), hospital survival (OR 0.48, 95% CI 0.37-0.62, p < 0.001), and favorable neurological outcomes (OR 0.42, 95% CI 0.30-0.57, p < 0.001). CONCLUSION: In this cohort of OHCA patients, the use of prehospital IO drug administration was associated with unfavorable clinical outcomes.

Proximal humerus intraosseous infusion: a preferred emergency venous access.

PURPOSE: To assess the proximal humerus intraosseous (PHIO) catheter placement as a preferred method for venous access over conventional methods, including peripheral intravenous (PIV) and central venous catheters (CVCs), during emergency room resuscitation. METHODS: In phase 1, conventional methods for venous access (PIV and CVC) were assessed for all patients presenting to the emergency department resuscitation bay. Outcome measures in both phases were speed, immediate complications, and pain. CVC placement was performed when PIV access was deemed impossible or when rapid volume resuscitation was needed. In phase 2, resuscitations requiring venous access or complicated by failed PIV access attempts underwent PHIO catheter placement. RESULTS: Sixty-two patients received either PIV (57) or CVC (5) catheterization, and 29 patients received 30 PHIO catheters. PHIO catheter placement was significantly faster than conventional methods (1.5 [SD 1.1] versus 3.6 minutes [SD 3.7; p < 0.001 for PIV, and 15.6 minutes [SD 6.7; p < 0.0056] for CVC). No major complications were identified in either phase. Minor complications for PIV access included extravasation and placement failure. Minor complications for CVC placement included inability to thread the guidewire. Minor complications with PHIO catheter placement included placement failure, poor flow, and catheter dislodgement. Pain scores associated with PHIO insertion and infusion were higher than those associated with PIV and CVC catheter placement. CONCLUSION: PHIO catheter placement is significantly faster than PIV and CVC placement with increased minor complication profile and perceived pain. PHIO venous access is absolutely life saving when PIV or CVC placement is difficult or impossible.

Academic emergency medicine faculty and industry relationships.

OBJECTIVES: The authors surveyed the membership of the Society for Academic Emergency Medicine (SAEM) about their associations with industry and predictors of those associations. METHODS: A national Web-based survey inviting faculty from the active member list of SAEM was conducted. Follow-up requests for participation were sent weekly for 3 weeks. Information was collected on respondents' personal and practice characteristics, industry interactions, and personal opinions regarding these interactions. Raw response rates were reported and a logistic regression was used to generate descriptive statistics. RESULTS: Responses were received from 430 members, representing 14% of the 3,183 active members. Respondents were 83% male and 86% white, with 96% holding an MD degree (24% with an additional postdoctoral degree). Most were at the assistant (37%) or associate (25%) professor rank, with 51% holding at least one leadership position. Most respondents (82%) reported some type of industry interaction, most commonly the acceptance of food or beverages (67%). Respondents at the associate professor rank or higher were more likely to receive payments from industry (51% vs. 22%, odds ratio [OR] = 3.7). CONCLUSIONS: This survey suggests that interactions between industry and academic EM faculty are common and increase with academic rank, but not with years in practice or leadership influence. The number and type of interactions are consistent with those reported by a national sampling of other physician specialties.

Survey of Emergency Department Chemical Hazard Preparedness in Michigan, USA: A Seven Year Comparison.

OBJECTIVE: To compare the state of chemical hazard preparedness in emergency departments (EDs) in Michigan, USA between 2005 and 2012. METHODS: This was a longitudinal study involving a 30 question survey sent to ED directors at each hospital listed in the Michigan College of Emergency Physician (MCEP) Directory in 2005 and in 2012. The surveys contained questions relating to chemical, biological, radiological, nuclear, and explosive events with a focus on hazardous material capabilities. RESULTS: One hundred twelve of 139 EDs responded to the 2005 survey compared to 99/136 in 2012. Ten of 27 responses were statistically significant, all favoring an enhancement in disaster preparedness in 2012 when compared to 2005. Questions with improvement included: EDs with employees participating in the Michigan voluntary registry; EDs with decontamination rooms; MARK 1 and cyanide kits available; those planning to use dry decontamination, powered air purifiers, surgical masks, chemical gloves, and surgical gowns; and those wishing for better coordination with local and regional resources. Forty-two percent of EDs in 2012 had greater than one-half of their staff trained in decontamination and 81% of respondents wished for more training opportunities in disaster preparedness. Eighty-four percent of respondents believed that they were more prepared in disaster preparedness in 2012 versus seven years prior. CONCLUSIONS: Emergency departments in Michigan have made significant advances in chemical hazard preparedness between 2005 and 2012 based on survey responses. Despite these improvements, staff training in decontamination and hazardous material events remains a weakness among EDs in the state of Michigan.

Blackout 2003: preparedness and lessons learned from the perspectives of four hospitals.

INTRODUCTION: The blackout in North America of August 2003 was one of the worst on record. It affected eight US states and parts of Canada for >24 hours. Additionally, two large US cities, Detroit, Michigan and Cleveland, Ohio, suffered from a loss of water pressure and a subsequent ban on the use of public supplies of potable water that lasted four days. A literature review revealed a paucity of literature that describes blackouts and how they may affect the medical community. METHODS: This paper includes a review of after-action reports from four inner-city, urban hospitals supplemented accounts from the authors' hospital's emergency operations center (EOC). RESULTS: Some of the problems encountered, included: (1)lighting; (2) elevator operations; (3) supplies of water; (4) communication operations; (5) computer failure; (6) lack of adequate supplies of food; (7) mobility to obtain X-ray studies; (8) heating, air condition, and ventilation; (9) staffing; (10) pharmacy; (11) registration of patients; (12) hospital EOC; (13) loss of isolation facilities; (14) inadequate supplies of paper; (15) impaired ability to provide care for non-emergency patients; (16) sanitation; and (17) inadequate emergency power. DISCUSSION: The blackout of 2003 uncovered problems within the US hospital system, ranging from staffing to generator coverage. This report is a review of the effects that the blackout and water ban of 2003 had on hospitals in a large inner-city area. Also discussed are solutions utilized at the time and recommendations for the future. CONCLUSION: The blackout of 2003 was an excellent test of disaster/emergency planning, and produced many valuable lessons to be used in future events.

Infrequent causes of stroke.

Infrequent causes of stroke are likely to be encountered by emergency physicians. Infrequent causes of stroke can be recalled using the ABC-IT mnemonic. Of the many infrequent causes, the five conditions more likely to be encountered are sickle cell anemia, migrainous stroke, antiphospholipid antibody syndrome, arterial dissection, and cocaine-related stroke. Consideration of the use of thrombolytic therapy in a patient with stroke from any cause lies at the forefront of treatment strategy in the emergency department.

A trial of levofloxacin 750 mg once daily for 5 days versus ciprofloxacin 400 mg and/or 500 mg twice daily for 10 days in the treatment of acute pyelonephritis.

OBJECTIVE: A double-blind, noninferiority trial was conducted to establish the safety and efficacy of a once-daily, 5-day course of levofloxacin 750 mg compared to a twice-daily, 10-day course of ciprofloxacin in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). This report focuses on subjects with AP. RESEARCH DESIGN AND METHODS: Adult male and female subjects with clinical signs and symptoms of AP and laboratory confirmation of their diagnosis were randomized to receive one dose of levofloxacin 750 mg once daily intravenously (i.v.) or orally and one dose of placebo for 5 days, followed by placebo; or ciprofloxacin 400 mg i.v. and/or 500 mg orally twice daily for 10 days. MAIN OUTCOME MEASURES: The primary, prospectively defined end point was microbiologic eradication at post-therapy (study days 15-22). Secondary outcomes included clinical response and safety and tolerability. RESULTS: In the modified intent-to-treat (mITT) population (levofloxacin 94, ciprofloxacin 98), 83% of levofloxacin-treated and 79.6% of ciprofloxacin-treated subjects achieved microbiological eradication (difference -3.4, 95% CI -14.4%, 7.6%). In the microbiologically evaluable (ME) population (levofloxacin 80, ciprofloxacin 76), 92.5% of levofloxacin-treated vs. 93.4% of ciprofloxacin-treated subjects (difference -0.9, 95% CI -7.1%, 8.9%) achieved microbiologic eradication. Clinical success was achieved in 86.2% vs. 80.6% (mITT) and in 92.5% vs. 89.5% (ME) of levofloxacin-treated and ciprofloxacin-treated subjects, respectively. Escherichia coli was the most commonly isolated uropathogen. Few (2.1%) of the pathogens were fluoroquinolone-resistant. Adverse events (AEs) were similar to those seen previously with both agents. Potential limitations are that this analysis is based on a subset of subjects from a larger study and, because of different durations of therapy, the results may be biased against levofloxacin. CONCLUSIONS: High-dose, short-course therapy with levofloxacin in subjects with AP is at least as effective as standard 10-day therapy with ciprofloxacin.