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The Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care Trial of very early intravenous glucose-insulin-potassium (GIK) for acute coronary syndromes (ACS) in out-of-hospital emergency medical service (EMS) settings showed 80% reduction in infarct size at 30 days, suggesting potential longer-term benefits. Here we report 1-year outcomes. Prespecified 1-year end points of this randomized, placebo-controlled, double-blind, effectiveness trial included all-cause mortality and composites including cardiac arrest, mortality, or hospitalization for heart failure (HF). Of 871 participants randomized to GIK versus placebo, death occurred within 1 year in 11.6% versus 13.5%, respectively (unadjusted hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.57 to 1.23, p = 0.36). The composite of cardiac arrest or 1-year mortality was 12.8% versus 17.0% (HR 0.71, 95% CI 0.50 to 1.02, p = 0.06). The composite of hospitalization for HF or mortality within 1 year was 17.2% versus 17.2% (HR 0.98, 95% CI 0.70 to 1.37, p = 0.92). The composite of mortality, cardiac arrest, or HF hospitalization within 1 year was 18.1% versus 20.4% (HR 0.85, 95% CI 0.62 to 1.16, p = 0.30). In patients presenting with suspected ST elevation myocardial infarction, HRs for 1-year mortality and the 3 composites were, respectively, 0.65 (95% CI 0.33 to 1.27, p = 0.21), 0.52 (95% CI 0.30 to 0.92, p = 0.03), 0.63 (95% CI 0.35 to 1.16, p = 0.14), and 0.51 (95% CI 0.30 to 0.87, p = 0.01). In patients with suspected acute coronary syndromes, serious end points generally were lower with GIK than placebo, but the differences were not statistically significant. However, in those with ST elevation myocardial infarction, the composites of cardiac arrest or 1-year mortality, and of cardiac arrest, mortality, or HF hospitalization within 1 year, were significantly reduced.
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Síndrome Coronario Agudo/tratamiento farmacológico , Atención Posterior/métodos , Pacientes Ambulatorios , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/mortalidad , Adulto , Soluciones Cardiopléjicas , Causas de Muerte/tendencias , Método Doble Ciego , Electrocardiografía , Femenino , Estudios de Seguimiento , Glucosa/administración & dosificación , Paro Cardíaco/mortalidad , Paro Cardíaco/prevención & control , Humanos , Infusiones Intravenosas , Insulina/administración & dosificación , Masculino , Persona de Mediana Edad , Miocardio/metabolismo , Potasio/administración & dosificación , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
INTRODUCTION: We sought to develop and test a computer-based, interactive simulation of a hypothetical pandemic influenza outbreak. Fidelity was enhanced with integrated video and branching decision trees, built upon the 2007 federal planning assumptions. We conducted a before-and-after study of the simulation effectiveness to assess the simulations' ability to assess participants' beliefs regarding their own hospitals' mass casualty incident preparedness. DEVELOPMENT: Using a Delphi process, we finalized a simulation that serves up a minimum of over 50 key decisions to 6 role-players on networked laptops in a conference area. The simulation played out an 8-week scenario, beginning with pre-incident decisions. TESTING: Role-players and trainees (N=155) were facilitated to make decisions during the pandemic. Because decision responses vary, the simulation plays out differently, and a casualty counter quantifies hypothetical losses. The facilitator reviews and critiques key factors for casualty control, including effective communications, working with external organizations, development of internal policies and procedures, maintaining supplies and services, technical infrastructure support, public relations and training. Pre- and post-survey data were compared on trainees. RESULTS: Post-simulation trainees indicated a greater likelihood of needing to improve their organization in terms of communications, mass casualty incident planning, public information and training. Participants also recognized which key factors required immediate attention at their own home facilities. CONCLUSION: The use of a computer-simulation was effective in providing a facilitated environment for determining the perception of preparedness, evaluating general preparedness concepts and introduced participants to critical decisions involved in handling a regional pandemic influenza surge.
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CONTEXT: Laboratory studies suggest that in the setting of cardiac ischemia, immediate intravenous glucose-insulin-potassium (GIK) reduces ischemia-related arrhythmias and myocardial injury. Clinical trials have not consistently shown these benefits, possibly due to delayed administration. OBJECTIVE: To test out-of hospital emergency medical service (EMS) administration of GIK in the first hours of suspected acute coronary syndromes (ACS). DESIGN, SETTING, AND PARTICIPANTS: Randomized, placebo-controlled, double-blind effectiveness trial in 13 US cities (36 EMS agencies), from December 2006 through July 31, 2011, in which paramedics, aided by electrocardiograph (ECG)-based decision support, randomized 911 (871 enrolled) patients (mean age, 63.6 years; 71.0% men) with high probability of ACS. INTERVENTION: Intravenous GIK solution (n = 411) or identical-appearing 5% glucose placebo (n = 460) administered by paramedics in the out-of-hospital setting and continued for 12 hours. MAIN OUTCOME MEASURES: The prespecified primary end point was progression of ACS to myocardial infarction (MI) within 24 hours, as assessed by biomarkers and ECG evidence. Prespecified secondary end points included survival at 30 days and a composite of prehospital or in-hospital cardiac arrest or in-hospital mortality, analyzed by intent-to-treat and by presentation with ST-segment elevation. RESULTS: There was no significant difference in the rate of progression to MI among patients who received GIK (n = 200; 48.7%) vs those who received placebo (n = 242; 52.6%) (odds ratio [OR], 0.88; 95% CI, 0.66-1.13; P = .28). Thirty-day mortality was 4.4% with GIK vs 6.1% with placebo (hazard ratio [HR], 0.72; 95% CI, 0.40-1.29; P = .27). The composite of cardiac arrest or in-hospital mortality occurred in 4.4% with GIK vs 8.7% with placebo (OR, 0.48; 95% CI, 0.27-0.85; P = .01). Among patients with ST-segment elevation (163 with GIK and 194 with placebo), progression to MI was 85.3% with GIK vs 88.7% with placebo (OR, 0.74; 95% CI, 0.40-1.38; P = .34); 30-day mortality was 4.9% with GIK vs 7.7% with placebo (HR, 0.63; 95% CI, 0.27-1.49; P = .29). The composite outcome of cardiac arrest or in-hospital mortality was 6.1% with GIK vs 14.4% with placebo (OR, 0.39; 95% CI, 0.18-0.82; P = .01). Serious adverse events occurred in 6.8% (n = 28) with GIK vs 8.9% (n = 41) with placebo (P = .26). CONCLUSIONS: Among patients with suspected ACS, out-of-hospital administration of intravenous GIK, compared with glucose placebo, did not reduce progression to MI. Compared with placebo, GIK administration was not associated with improvement in 30-day survival but was associated with lower rates of the composite outcome of cardiac arrest or in-hospital mortality. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00091507.
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Síndrome Coronario Agudo/tratamiento farmacológico , Soluciones Cardiopléjicas/uso terapéutico , Infarto del Miocardio/prevención & control , Síndrome Coronario Agudo/mortalidad , Anciano , Técnicos Medios en Salud , Angina Inestable/complicaciones , Angina Inestable/tratamiento farmacológico , Técnicas de Apoyo para la Decisión , Método Doble Ciego , Electrocardiografía , Servicios Médicos de Urgencia , Femenino , Glucosa/uso terapéutico , Paro Cardíaco/prevención & control , Mortalidad Hospitalaria , Humanos , Insulina/uso terapéutico , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Oportunidad Relativa , Potasio/uso terapéutico , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: Admission rates among patients presenting to emergency departments with possible acute coronary syndromes are high, although for most of these patients, the symptoms are ultimately found not to have a cardiac cause. Coronary computed tomographic angiography (CCTA) has a very high negative predictive value for the detection of coronary disease, but its usefulness in determining whether discharge of patients from the emergency department is safe is not well established. METHODS: We randomly assigned low-to-intermediate-risk patients presenting with possible acute coronary syndromes, in a 2:1 ratio, to undergo CCTA or to receive traditional care. Patients were enrolled at five centers in the United States. Patients older than 30 years of age with a Thrombolysis in Myocardial Infarction risk score of 0 to 2 and signs or symptoms warranting admission or testing were eligible. The primary outcome was safety, assessed in the subgroup of patients with a negative CCTA examination, with safety defined as the absence of myocardial infarction and cardiac death during the first 30 days after presentation. RESULTS: We enrolled 1370 subjects: 908 in the CCTA group and 462 in the group receiving traditional care. The baseline characteristics were similar in the two groups. Of 640 patients with a negative CCTA examination, none died or had a myocardial infarction within 30 days (0%; 95% confidence interval [CI], 0 to 0.57). As compared with patients receiving traditional care, patients in the CCTA group had a higher rate of discharge from the emergency department (49.6% vs. 22.7%; difference, 26.8 percentage points; 95% CI, 21.4 to 32.2), a shorter length of stay (median, 18.0 hours vs. 24.8 hours; P<0.001), and a higher rate of detection of coronary disease (9.0% vs. 3.5%; difference, 5.6 percentage points; 95% CI, 0 to 11.2). There was one serious adverse event in each group. CONCLUSIONS: A CCTA-based strategy for low-to-intermediate-risk patients presenting with a possible acute coronary syndrome appears to allow the safe, expedited discharge from the emergency department of many patients who would otherwise be admitted. (Funded by the Commonwealth of Pennsylvania Department of Health and the American College of Radiology Imaging Network Foundation; ClinicalTrials.gov number, NCT00933400.).
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Síndrome Coronario Agudo/diagnóstico por imagen , Angiografía Coronaria , Enfermedad Coronaria/diagnóstico por imagen , Síndrome Coronario Agudo/mortalidad , Adulto , Anciano , Intervalos de Confianza , Angiografía Coronaria/métodos , Enfermedad Coronaria/diagnóstico , Enfermedad Coronaria/terapia , Femenino , Recursos en Salud/estadística & datos numéricos , Hospitalización , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Alta del Paciente , Tomografía Computarizada por Rayos XRESUMEN
INTRODUCTION: Surge capacity for optimization of access to hospital beds is a limiting factor in response to catastrophic events. Medical facilities, communication tools, manpower, and resource reserves exist to respond to these events. However, these factors may not be optimally functioning to generate an effective and efficient surge response. The objective was to improve the function of these factors. METHODS: Regional healthcare facilities and supporting local emergency response agencies developed a coalition (the Healthcare Facilities Partnership of South Central Pennsylvania; HCFP-SCPA) to increase regional surge capacity and emergency preparedness for healthcare facilities. The coalition focused on 6 objectives: (1) increase awareness of capabilities and assets, (2) develop and pilot test advanced planning and exercising of plans in the region, (3) augment written medical mutual aid agreements, (4) develop and strengthen partnership relationships, (5) ensure National Incident Management System compliance, and (6) develop and test a plan for effective utilization of volunteer healthcare professionals. RESULTS: In comparison to baseline measurements, the coalition improved existing areas covered under all 6 objectives documented during a 24-month evaluation period. Enhanced communications between the hospital coalition, and real-time exercises, were used to provide evidence of improved preparedness for putative mass casualty incidents. CONCLUSION: The HCFP-SCPA successfully increased preparedness and surge capacity through a partnership of regional healthcare facilities and emergency response agencies.