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Several cardiovascular conditions exhibit seasonality in frequency and mortality, but little is known about the seasonality of Venous ThromboEmbolism (VTE), a very relevant medical condition, and seasonal influences are still conflicting. Patients having co-morbidities, individual suffered from dyspnea, swelling, edema of lower limb, pain (chest, lower limbs) are admitted frequently to the hospital emergency room (HER), particularly. Both mark a potential risk for VTE, that can be increased also by seasonality. A four years retrospective analysis (2016-2019) was carried out in individuals and patients admitted to the HER of the Hospital of Catania (a Mediterranean city of Sicily, Italy) to evaluate the VTE frequency and its seasonal differences, common symptoms, potential usage of some common laboratory tests. Dyspnea, swelling, edema of lower limb and pain (chest, lower limbs) were considered to suspect pulmonary embolism (PE) or for deep vein thrombosis of lower limb (DVT). Platelet count, platelet volume, fibrinogen, C-reactive protein, and D-dimer were considered. VTE frequency per year was 2.9/10,000 (2016), 4.9/10,000 (2017) 3.6/10,000 (2018), and 5.1/10,000 (2019) respectively. Dyspnea was highly frequent for PE, edema and lower limb pain were frequent in DVT patients. Fibrinogen, C reactive protein, and D-dimer values were found raised in all the VTE patients. Platelet volume was found higher in DVT than PE VTE events that occurred in warm periods were modestly greater (57 VTE: 38 DVT, 19 PE) compared to cold months (52 VTE: 34 DVT, 18 PE). Our results could be explained by the increased sweating due to the high temperatures, which in turn, can affect both on plasma concentration and on hematocrit value coupled to the reduction in atmospheric pressure determining both a hyper-coagulative condition. Climate seasonal characteristics, and environmental conditions in Catania city (Sicily) may be as reasonable items in expecting on different VTE rates in warm period compared to cold. This study highlights no specific symptoms, and confirms the common lab tests for individuals and patients admitted to HER as simple and helpful tools in initiating none or mini-invasive diagnostic strategy for the VTE. Finally, the climate/seasonality coupled with latitude can have a direct influence on the incidence of DVT.
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Tromboembolia Venosa , Trombosis de la Vena , Servicio de Urgencia en Hospital , Hospitales , Humanos , Estudios Retrospectivos , Factores de Riesgo , Sicilia , Tromboembolia Venosa/epidemiologíaRESUMEN
BACKGROUND: Non-invasive ventilation (NIV) is increasingly used to support very old (aged ≥85 years) patients with acute respiratory failure (ARF). This retrospective observational study evaluated the impact of NIV on the prognosis of very old patients who have been admitted to the intermediate care unit (IMC) of the Emergency Department of the University Hospital Policlinico-Vittorio Emanuele of Catania for ARF. METHODS: All patients admitted to the IMC between January and December 2015 who received NIV as the treatment for respiratory failure were included in this study. Outcomes of patients aged ≥85 years were compared with lower ages. The expected intrahospital mortality was calculated through the Simplified Acute Physiology Score (SAPS) II and compared with the observed mortality. RESULTS: The mean age was 87.9±2.9 years; the M:F ratio was approximately 1:3. The average SAPS II was 50.1±13.7. The NIV failure rate was 21.7%. The mortality in the very old group was not statistically different from the younger group (20% vs 25.6%; d=5.6%; 95% CI -8% to 19%; p=0.404). The observed mortality was significantly lower than the expected mortality in both the group ≥85 (20.0% vs 43.4%, difference=23.4%; 95% CI 5.6% to 41.1%, p=0.006) and the younger group (25.6% vs 38.5%, difference=12.9%; 95% CI -0.03% to 25.8%, p=0.046). In both age groups, patients treated with NIV for chronic obstructive pulmonary disease had lower mortalities than those treated for other illnesses, although this was statistically significant only in the younger group. CONCLUSION: In very old patients, when used with correct indications, NIV was associated with mortality similar to younger patients. Patients receiving NIV had lower than expected mortality in all age groups.
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Ventilación no Invasiva/normas , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Insuficiencia Respiratoria/terapia , Anciano , Anciano de 80 o más Años , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Ventilación no Invasiva/métodos , Evaluación de Resultado en la Atención de Salud/métodos , Insuficiencia Respiratoria/mortalidad , Estudios Retrospectivos , Puntuación Fisiológica Simplificada Aguda , Insuficiencia del TratamientoAsunto(s)
Cuidados Críticos , Pandemias , Ocupación de Camas , Hospitales , Humanos , Intubación IntratraquealRESUMEN
BACKGROUND: Pulmonary congestion is indicated at lung ultrasound by detection of B-lines, but correlation of these ultrasound signs with pulmonary artery occlusion pressure (PAOP) and extravascular lung water (EVLW) still remains to be further explored. The aim of the study was to assess whether B-lines, and eventually a combination with left ventricular ejection fraction (LVEF) assessment, are useful to differentiate low/high PAOP and EVLW in critically ill patients. METHODS: The authors enrolled 73 patients requiring invasive monitoring from the intensive care unit of four university-affiliated hospitals. Forty-one patients underwent PAOP measurement by pulmonary artery catheterization and 32 patients had EVLW measured by transpulmonary thermodilution method. Lung and cardiac ultrasound examinations focused to the evaluation of B-lines and gross estimation of LVEF were performed. The absence of diffuse B-lines (A-pattern) versus the pattern showing prevalent B-lines (B-pattern) and the combination with normal or impaired LVEF were correlated with cutoff levels of PAOP and EVLW. RESULTS: PAOP of 18 mmHg or less was predicted by the A-pattern with 85.7% sensitivity (95% CI, 70.5 to 94.1%) and 40.0% specificity (CI, 25.4 to 56.4%), whereas EVLW 10 ml/kg or less with 81.0% sensitivity (CI, 62.6 to 91.9%) and 90.9% specificity (CI, 74.2 to 97.7%). The combination of A-pattern with normal LVEF increased sensitivity to 100% (CI, 84.5 to 100%) and specificity to 72.7% (CI, 52.0 to 87.2%) for the prediction of PAOP 18 mmHg or less. CONCLUSIONS: B-lines allow good prediction of pulmonary congestion indicated by EVLW, whereas are of limited usefulness for the prediction of hemodynamic congestion indicated by PAOP. Combining B-lines with estimation of LVEF at transthoracic ultrasound may improve the prediction of PAOP.
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Agua Pulmonar Extravascular/fisiología , Pulmón/diagnóstico por imagen , Presión Esfenoidal Pulmonar/fisiología , Adulto , Anciano , Anciano de 80 o más Años , Enfermedad Crítica , Ecocardiografía , Femenino , Hemodinámica/fisiología , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Arteria Pulmonar/diagnóstico por imagen , Arteria Pulmonar/fisiología , Volumen Sistólico/fisiología , Resultado del Tratamiento , Adulto JovenRESUMEN
INTRODUCTION: Mid-regional pro-atrial natriuretic peptide (MR-proANP), procalcitonin (PCT), and mid-regional pro-adrenomedullin (MR-proADM) demonstrated usefulness for management of emergency department patients with dyspnea. METHODS: To evaluate in patients with dyspnea, the prognostic value for 30 and 90 days mortality and readmission of PCT, MR-proADM, and MR-proANP, a multicenter prospective study was performed evaluating biomarkers at admission, 24 and 72 hours after admission. Based on final diagnosis, patients were divided into acute heart failure (AHF), primary lung diseases, or both (AHF + NO AHF). RESULTS: Five hundred one patients were enrolled. Procalcitonin and MR-proADM values at admission and at 72 hours were significantly (P < .001) predictive for 30-day mortality: baseline PCT with an area under the curve (AUC) of 0.70 and PCT at 72 hours with an AUC of 0.61; baseline MR-proADM with an AUC of 0.62 and MR-proADM at 72 hours with an AUC of 0.68. As for 90-day mortality, both PCT and MR-proADM baseline and 72 hours values showed a significant (P < .0001) predictive ability: baseline PCT with an AUC of 0.73 and 72 hours PCT with an AUC of 0.64; baseline MR-proADM with an AUC of 0.66 and 72 hours MR-proADM with an AUC of 0.71. In AHF, group biomarkers predicted rehospitalization and mortality at 90 days, whereas in AHF + NO AHF group, they predict mortality at 30 and 90 days. CONCLUSIONS: In patients admitted for dyspnea, assessment of PCT plus MR-proADM improves risk stratification and management. Combined use of biomarkers is able to predict in the total cohort both rehospitalization and death at 30 and 90 days.
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Adrenomedulina/sangre , Calcitonina/sangre , Disnea/sangre , Disnea/mortalidad , Insuficiencia Cardíaca/sangre , Insuficiencia Cardíaca/mortalidad , Enfermedades Pulmonares/sangre , Enfermedades Pulmonares/mortalidad , Precursores de Proteínas/sangre , Anciano , Anciano de 80 o más Años , Biomarcadores/sangre , Péptido Relacionado con Gen de Calcitonina , Servicio de Urgencia en Hospital , Femenino , Mortalidad Hospitalaria , Humanos , Italia/epidemiología , Masculino , Admisión del Paciente/estadística & datos numéricos , Valor Predictivo de las Pruebas , Pronóstico , Estudios Prospectivos , Medición de RiesgoRESUMEN
BACKGROUND: In the last few years, several nicotine products have become available as alternatives to smoking tobacco. While laboratory and limited clinical studies suggest that these devices are less toxic compared to classic tobacco cigarettes, very little is known about their epidemiological impact. Visiting the emergency department (ED) often represents the first or even the only contact of patients with the health care system. Therefore, a study conducted at the ED to assess the impact of these products on health can be reliable and reflect a real-life setting. OBJECTIVE: The aim of this noninterventional observational study (SMOPHED study) is to analyze the association between the severity of clinical presentation observed during ED visits among patients using various nicotine products and the subsequent outcomes, specifically hospitalization and mortality. METHODS: Outcomes (hospitalization and mortality in the ED) will be examined in relation to various patterns of nicotine products use. We plan to enroll approximately 2000 participants during triage at the ED. These individuals will be characterized based on their patterns of tobacco and nicotine consumption, identified through a specific questionnaire. This categorization will allow for a detailed analysis of how different usage patterns of nicotine products correlate with the clinical diagnosis made during the ED visits and the consequent outcomes. RESULTS: Enrollment into the study started in March 2024. We enrolled a total of 901 participants in 1 month (approximately 300 potential participants did not provide the informed consent to participate). The data will be analyzed by a statistician as soon as the database is completed. Full data will be published by December 2024. CONCLUSIONS: There is substantial debate about the harm reduction potential of alternative nicotine products in terms of their smoking-cessation and risk-reduction potential. This study represents an opportunity to document epidemiological data on the link between the use of different types of nicotine products and disease diagnosis and severity during an ED visit, and thus evaluate the harm reduction potential claims for these products. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54041.
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Servicio de Urgencia en Hospital , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Servicio de Urgencia en Hospital/estadística & datos numéricos , Hospitalización/estadística & datos numéricos , Nicotina/efectos adversos , Estudios Observacionales como Asunto , Fenotipo , Índice de Severidad de la Enfermedad , Fumar Tabaco/epidemiología , Fumar Tabaco/efectos adversosRESUMEN
INTRODUCTION: Acute kidney injury (AKI) is a common complication among hospitalized patients. The aim of this study was to evaluate the utility of blood neutrophil gelatinase-associated lipocalin (NGAL) assessment as an aid in the early risk evaluation for AKI development in admitted patients. METHODS: This is a multicenter Italian prospective emergency department (ED) cohort study in which we enrolled 665 patients admitted to hospital from the ED. RESULTS: Blood NGAL and serum creatinine (sCr) were determined at ED presentation (T0), and at: 6 (T6), 12 (T12), 24 (T24) and 72 (T72) hours after hospitalization. A preliminary assessment of AKI by the treating ED physician occurred in 218 out of 665 patients (33%), while RIFLE AKI by expert nephrologists was confirmed in 49 out of 665 patients (7%). The ED physician's initial judgement lacked sensitivity and specificity, overpredicting the diagnosis of AKI in 27% of the cohort, while missing 20% of those with AKI as a final diagnosis. CONCLUSIONS: Our study demonstrated that assessment of a patient's initial blood NGAL when admitted to hospital from the ED improved the initial clinical diagnosis of AKI and predicted in-hospital mortality. Blood NGAL assessment coupled with the ED physician's clinical judgment may prove useful in deciding the appropriate strategies for patients at risk for the development of AKI.See related commentary by Legrand et al., http://ccforum.com/content/17/2/132.
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Lesión Renal Aguda/sangre , Lesión Renal Aguda/diagnóstico , Servicio de Urgencia en Hospital , Mortalidad Hospitalaria , Juicio , Lipocalinas/sangre , Proteínas Proto-Oncogénicas/sangre , Lesión Renal Aguda/mortalidad , Proteínas de Fase Aguda , Anciano , Anciano de 80 o más Años , Biomarcadores/sangre , Estudios de Cohortes , Servicio de Urgencia en Hospital/tendencias , Femenino , Mortalidad Hospitalaria/tendencias , Hospitalización/tendencias , Humanos , Lipocalina 2 , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios ProspectivosRESUMEN
Due to the COVID-19 pandemic, there has been a shift in focus towards controlling the spread of SARS-CoV-2, which has resulted in the neglect of traditional programs aimed at preventing healthcare-associated infections and combating antimicrobial resistance. The present work aims to characterize the colonization or infection with Acinetobacter baumannii of COVID-19 patients and to identify any clonality between different isolates. Specifically, data and resistance profiles of A. baumannii isolates were prospectively collected from patients recruited by the EPIRADIOCLINF project. Pulsed-field gel electrophoresis (PFGE) and multi-locus sequence typing (MLST) were used for molecular typing. Overall, we analyzed 64 isolates of A. baumannii from 48 COVID-19 patients. According to our analysis, we have identified the spread of a clonally related isolate, referred to as B. The PFGE pattern B includes four subtypes: B1 (consisting of 37 strains), B2 (11), B3 (5), and B4 (2). Furthermore, in the isolates that were examined using MLST, the most observed sequence type was ST/281. In terms of resistance profiles, 59 out of the total isolates (92.2%) were found to be resistant to gentamicin, carbapenems, ciprofloxacin, and tobramycin. The isolation and identification of A. baumannii from COVID-19 patients, along with the high levels of transmission observed within the hospital setting, highlight the urgent need for the implementation of effective prevention and containment strategies.
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The neutrophil-to-lymphocyte ratio (NLR) is an inflammatory marker predicting the prognosis of several diseases. We aimed to assess its role as a predictor of mortality or admission to the intensive care unit in COVID-19 patients. We retrospectively evaluated a cohort of 411 patients with COVID-19 infection. The neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and C-reactive protein (CRP) of patients with COVID-19 were compared. The median age of our sample was 72 years (interquartile range: 70−75); 237 were males. Hypertension, diabetes and ischemic heart disease were the most common comorbidities. The study population was subdivided into three groups according to NLR tertiles. Third-tertile patients were older, showing significantly higher levels of inflammatory markers; 133 patients (32%) died during hospitalization, 81 of whom belonged to the third tertile; 79 patients (19%) were admitted to ICU. NLR showed the largest area under the curve (0.772), with the highest specificity (71.9%) and sensitivity (72.9%), whereas CRP showed lower sensitivity (60.2%) but slightly higher specificity (72.3%). Comparisons between NLR and CRP ROC curves were significantly different (p = 0.0173). Cox regression models showed that the association between NLR and death was not weakened after adjustment for confounders. Comparisons of ROC curves showed no significant differences between NLR, PLR, and CRP. Cox regression analysis showed that NLR predicted the risk of admission to ICU independently of demographic characteristics and comorbidities (HR: 3.9597, p < 0.0001). These findings provide evidence that NLR is an independent predictor of mortality and a worse outcome in COVID-19 patients and may help identify high-risk individuals with COVID-19 infection at admission.
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INTRODUCTION: Our aim was to evaluate the role of B-type natriuretic peptide (BNP) percentage variations at 24 hours and at discharge compared to its value at admission in order to demonstrate its predictive value for outcomes in patients with acute decompensated heart failure (ADHF). METHODS: This was a multicenter Italian (8 centers) observational study (Italian Research Emergency Department: RED). 287 patients with ADHF were studied through physical exams, lab tests, chest X Ray, electrocardiograms (ECGs) and BNP measurements, performed at admission, at 24 hours, and at discharge. Follow up was performed 180 days after hospital discharge. Logistic regression analysis was used to estimate odds ratios (OR) for the various subgroups created. For all comparisons, a P value < 0.05 was considered statistically significant. RESULTS: BNP median (interquartile range (IQR)) value at admission was 822 (412 - 1390) pg\mL; at 24 hours was 593 (270 - 1953) and at discharge was 325 (160 - 725). A BNP reduction of >46% at discharge had an area under curve (AUC) of 0.70 (P < 0.001) for predicting future adverse events. There were 78 events through follow up and in 58 of these patients the BNP level at discharge was >300 pg/mL. A BNP reduction of 25.9% after 24 hours had an AUC at ROC curve of 0.64 for predicting adverse events (P < 0.001). The odds ratio of the patients whose BNP level at discharge was <300 pg/mL and whose percentage decrease at discharge was <46% compared to the group whose BNP level at discharge was <300 pg/mL and whose percentage decrease at discharge was >46% was 4.775 (95% confidence interval (CI) 1.76 - 12.83, P < 0.002). The odds ratio of the patients whose BNP level at discharge was >300 pg/mL and whose percentage decrease at discharge was <46% compared to the group whose BNP level at discharge was <300 pg/mL and whose percentage decrease at discharge was >46% was 9.614 (CI 4.51 - 20.47, P < 0.001). CONCLUSIONS: A reduction of BNP >46% at hospital discharge compared to the admission levels coupled with a BNP absolute value < 300 pg/mL seems to be a very powerful negative prognostic value for future cardiovascular outcomes in patients hospitalized with ADHF.
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Insuficiencia Cardíaca/sangre , Pacientes Internos , Péptido Natriurético Encefálico/sangre , Enfermedad Aguda , Anciano , Anciano de 80 o más Años , Femenino , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/fisiopatología , Humanos , Italia , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Valor Predictivo de las Pruebas , PronósticoRESUMEN
PURPOSE: Opioid analgesics remain the cornerstone of treatment for severe trauma pain in the emergency setting, but there are barriers to their use. This post hoc analysis of a previously reported trial (MEDITA) investigated the efficacy and safety of low-dose methoxyflurane versus intravenous (IV) morphine for severe trauma pain. PATIENTS AND METHODS: MEDITA was a Phase IIIb, randomized, active-controlled, parallel-group, open-label study in Italian pre-hospital units and emergency departments (EudraCT: 2017-001565-25; NCT03585374). Adult patients (N=272) with moderate-to-severe trauma pain (score ≥4 on the Numerical Rating Scale [NRS]) were randomized 1:1 to inhaled methoxyflurane (3 mL) or standard analgesic treatment (SAT; IV paracetamol 1g or ketoprofen 100mg for moderate pain [NRS 4-6] and IV morphine 0.1mg/kg for severe pain [NRS ≥7]). Analyses were performed for the severe pain subgroup. The primary efficacy variable was the overall change from baseline in visual analog scale (VAS) pain intensity at 3, 5 and 10min post-randomization. Non-inferiority of methoxyflurane versus morphine was concluded if the upper 95% confidence interval (CI) for the treatment difference was <1; superiority was concluded if the upper 95% CI was <0. RESULTS: Ninety-three patients (methoxyflurane: 49; SAT: 44) were included in the severe pain intention-to-treat population. The reduction in VAS pain intensity over the first 10min was superior for methoxyflurane versus morphine (adjusted mean treatment difference: -5.54mm; 95% CI: -10.49, -0.59mm; p=0.029). Median time to onset of pain relief was 9min for methoxyflurane and 15min for morphine. Patients rated treatment efficacy and physicians rated treatment practicality "Excellent" or "Very good" for more methoxyflurane-treated patients (42.8% and 67.3%) than morphine-treated patients (18.1% and 22.8%). Adverse events, all non-serious, were reported in 20.4% of methoxyflurane-treated patients and in 4.8% of morphine-treated patients. CONCLUSION: Methoxyflurane provided superior short-term pain relief to IV morphine in patients with severe trauma pain and offers an effective non-narcotic treatment option.
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BACKGROUND: The aim of this study was to describe the population of patients arriving in several Italian Emergency Departments (EDs) complaining of chest pain suggestive of acute coronary syndrome (ACS) in order to evaluate the incidence of ACS in this cohort and the association between ACS and different clinical parameters and risk factors. METHODS: This is an observational prospective study, conducted from the 1st January to the 31st December 2014 in 11 EDs in Italy. Patients presenting to ED with chest pain, suggestive of ACS, were consecutively enrolled. RESULTS: Patients with a diagnosis of ACS (N.=1800) resulted to be statistically significant older than those without ACS (NO ACS; N.=4630) (median age: 70 vs. 59, P<0.001), and with a higher prevalence of males (66.1% in ACS vs. 57.5% in NO ACS, P<0.001). ECG evaluation, obtained at ED admission, showed new onset alterations in 6.2% of NO ACS and 67.4% of ACS patients. Multiple logistic regression analysis showed that the following parameters were predictive for ACS: age, gender, to be on therapy for cardio-vascular disease (CVD), current smoke, hypertension, hypercholesterolemia, heart rate, ECG alterations, increased BMI, reduced SaO2. CONCLUSIONS: Results from this observational study strengthen the importance of the role of the EDs in ruling in and out chest pain patients for the diagnosis of ACS. The analysis put in light important clinical and risk factors that, if promptly recognized, can help Emergency Physicians to identify patients who are more likely to be suffering from ACS.
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Síndrome Coronario Agudo/epidemiología , Dolor en el Pecho/epidemiología , Servicio de Urgencia en Hospital/estadística & datos numéricos , Sistema de Registros/estadística & datos numéricos , Síndrome Coronario Agudo/diagnóstico , Factores de Edad , Anciano , Femenino , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Análisis de Regresión , Factores de Riesgo , Factores SexualesRESUMEN
INTRODUCTION: Low-dose methoxyflurane, administered via a hand-held inhaler, has been used for short-term pain relief in emergency medicine in Australia and New Zealand for over 40 years, and was recently approved in Europe for the rapid relief of moderate-to-severe trauma-related pain in adults. There is currently a lack of data for methoxyflurane versus active comparators, therefore this trial will investigate the efficacy and safety of inhaled methoxyflurane compared with standard of care (SoC) in the treatment of acute trauma-related pain in pre-hospital and ED settings in Italy. METHODS: MEDITA (Methoxyflurane in Emergency Department in ITAly) is a Phase IIIb, prospective, randomised, active-controlled, parallel-group, open-label, multicentre trial. A total of 272 adult patients with moderate-to-severe pain [score ≥ 4 on the Numerical Rating Scale (NRS)] due to limb trauma will be randomised 1:1 to receive 3 mL methoxyflurane (self-administered by the patient via inhalation under supervision of a trained person) or medications that currently comprise the SoC in Italy [intravenous (IV) morphine for severe pain (NRS ≥ 7); IV paracetamol or ketoprofen for moderate pain (NRS 4-6)], administered as soon as possible after randomisation. PLANNED OUTCOMES: Pain intensity will be measured using a 100-mm visual analogue scale (VAS) at baseline (time of randomisation) and at intervals up to 30 min. Time of onset of pain relief as reported by the patient and use of rescue medication will be recorded. The patient will rate the efficacy and the healthcare professional will rate the practicality of study treatment at 30 min after randomisation using a 5-point Likert scale. Adverse events will be recorded until safety follow-up at 14 ± 2 days. Vital signs will be measured at baseline, 10 and 30 min. The primary aim is to demonstrate non-inferiority of methoxyflurane versus SoC for the change in VAS pain intensity from baseline (randomisation) to 3, 5 and 10 min. TRIAL REGISTRATION: EudraCT number: 2017-001565-25. Clinicaltrials.gov identifier: NCT03585374. FUNDING: Mundipharma Pharmaceuticals srl.
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Dolor Agudo/tratamiento farmacológico , Anestésicos por Inhalación/uso terapéutico , Servicios Médicos de Urgencia/métodos , Metoxiflurano/uso terapéutico , Administración por Inhalación , Adulto , Monitoreo de Drogas/métodos , Servicio de Urgencia en Hospital , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Manejo del Dolor/métodos , Dimensión del Dolor/métodos , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: The aim of this study was to assess prognostic stratification in patients admitted in two Italian Emergency-Department High-Dependency Units (ED-HDU). METHODS: From June 2014, to July 2016, we recorded all patients admitted in the ED-HDU of the Careggi University Hospital and the Vittorio Emanuele University Hospital in a standardized database. Charlson Index and SOFA Score were calculated to evaluate comorbidity burden and severity of organ dysfunction. End-points were HDU and in-hospital mortality rate and need of Intensive Care Unit (ICU) transfer. RESULTS: The overall number of patients admitted in the two Units was 3311, 1822 in Florence and 1489 in Catania. HDU mortality rate was 5% (N.=171); compared with survivors, non-survivors showed a higher SOFA Score (10.0±4.2 vs. 3.5±2.9, P<0.001) and a higher number of organ dysfunctions (1.6±0.9 vs. 0.6±0.8, P<0.001). All patients with a SOFA Score in the first and second quartile survived HDU admission (only two non-survivors among patients in the second quartile), while mortality was disproportionally high in the group with a score value in the fourth quartile (0%, 0.2%, 3% and 14%, P<0.001). Presence and number of organ failure, as well as SOFA Score (5.6±4.0 vs. 3.4±2.8, P<0.001), were significantly higher in patients transferred to ICU than in those admitted in an ordinary ward or discharged. A higher SOFA Score (RR 1.55, 95% CI: 1.47-1.63, P<0.001) was associated with an increased HDU mortality, independent of age and Charlson Index. CONCLUSIONS: SOFA Score showed a good discrimination ability for both HDU - mortality and indication to increase the level of care.
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Cuidados Críticos , Servicio de Urgencia en Hospital , Insuficiencia Multiorgánica/terapia , Puntuaciones en la Disfunción de Órganos , Anciano , Anciano de 80 o más Años , Grupos Diagnósticos Relacionados , Femenino , Mortalidad Hospitalaria , Humanos , Italia , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , PronósticoRESUMEN
INTRODUCTION: Inhaled low-dose methoxyflurane is approved in Europe for emergency relief of moderate-to-severe trauma-related pain in adults, but data versus active comparators are sparse. The phase IIIb Methoxyflurane in Emergency Department in ITAly (MEDITA) trial investigated the analgesic efficacy, practicality and safety of methoxyflurane versus standard analgesic treatment (SAT) for acute trauma pain. METHODS: This was a randomised, active-controlled, parallel-group, open-label trial conducted in 15 Italian emergency units. Adults with limb trauma and pain score ≥ 4 on numerical rating scale (NRS) were randomised 1:1 to inhaled methoxyflurane 3 mL or SAT [intravenously administered (IV) morphine 0.1 mg/kg for severe pain (NRS ≥ 7); IV paracetamol 1 g or IV ketoprofen 100 mg for moderate pain (NRS 4-6)]. The primary endpoint was overall change in visual analogue scale (VAS) pain intensity from baseline (time of randomisation) to 3, 5 and 10 min. Non-inferiority and superiority of methoxyflurane versus SAT were concluded if the upper 95% confidence interval (CI) for the treatment comparison (methoxyflurane-SAT) was less than 1 and less than 0, respectively. RESULTS: Between 8 February 2018 and 8 February 2019, 272 patients were randomised (136 per treatment group). A total of 270 patients (mean age 51 years; 49% male; 34% with severe pain; mean baseline VAS 67 mm) were treated and analysed for efficacy and safety. Superiority of methoxyflurane was demonstrated for moderate-to-severe pain (adjusted mean treatment difference - 5.94 mm; 95% CI - 8.83, - 3.06 mm), moderate pain (- 5.97 mm; 95% CI - 9.55, - 2.39 mm) and severe pain (- 5.54 mm; 95% CI - 10.49, - 0.59 mm). Median onset of pain relief was 9 min for methoxyflurane and 15 min for SAT. Practicality of methoxyflurane treatment was rated "Excellent", "Very Good" or "Good" by 90% of clinicians vs. 64% for SAT. Adverse events (all non-serious) were reported by 17% of methoxyflurane-treated patients and 3% of SAT-treated patients. CONCLUSION: Methoxyflurane provided superior pain relief to SAT in patients with moderate-to-severe trauma pain and may offer a simple, fast, effective non-opioid treatment option. TRIAL REGISTRATION: Trial registered with EudraCT (2017-001565-25) on 2 March 2018 and ClinicalTrials.gov (NCT03585374) on 13 July 2018. FUNDING: Mundipharma Pharmaceuticals S.r.l.
Asunto(s)
Dolor Agudo/tratamiento farmacológico , Anestésicos por Inhalación/administración & dosificación , Metoxiflurano/administración & dosificación , Heridas y Lesiones/complicaciones , Heridas y Lesiones/dietoterapia , Acetaminofén/administración & dosificación , Dolor Agudo/etiología , Administración Intravenosa , Adulto , Analgésicos/uso terapéutico , Relación Dosis-Respuesta a Droga , Servicio de Urgencia en Hospital , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Morfina/administración & dosificación , Manejo del Dolor , Resultado del TratamientoRESUMEN
BACKGROUND: Adverse drug events (ADEs) are a significant cause of emergency department (ED) visits, with a major impact on healthcare resource utilization. A multicentre observational study, aimed to describe frequency, seriousness and preventability of ADEs reported in four EDs, was performed in Sicily (Italy) over a 1-year period. METHODS: Two trained monitors for each ED supported clinicians in identifying ADEs of patients admitted to EDs between June 1st, 2013 and May 31st, 2014 through a systematic interview of patients or their caregivers and with an additional record review. A research team analyzed each case of suspected ADE, to make a causality assessment applying the Naranjo algorithm and a preventability assessment using Schumock and Thornton criteria. Absolute and percentage frequencies with 95% confidence interval (CI) and medians with interquartile ranges (IQR) were estimated. Logistic regression models were used to evaluate independent predictors of serious and certainly preventable ADEs. RESULTS: Out of 16,963 ED visits, 575 (3.4%) were associated to ADEs, of which 15.1% resulted in hospitalization. ADEs were classified as probable in 45.9%, possible in 51.7% and definite in 2.4% of the cases. Moreover, ADEs were considered certainly preventable in 12.3%, probably preventable in 58.4%, and not preventable in 29.2% of the cases. Polytherapy influenced the risk to experience a serious, as well as a certainly preventable ADE. Whilst, older age resulted an independent predictor only of serious events. The most common implicated drug classes were antibiotics (34.4%) and anti-inflammatory drugs (22.6%). ADEs due to psycholeptics and antiepileptics resulted preventable in 62.7 and 54.5% of the cases, respectively. Allergic reactions (64%) were the most frequent cause of ADE-related ED visits, followed by neurological effects (10.2%) that resulted preventable in 1.9 and 37.3% of the cases, respectively. CONCLUSION: ADEs are a frequent cause of ED visits. The commonly used antibiotics and anti-inflammatory drugs should be carefully managed, as they are widely involved in mild to severe ADEs. Polytherapy is associated with the occurrence of serious, as well as certainly preventable ADEs, while older age only with serious events. A greater sensitivity to drug monitoring programs among health professionals is needed.