Effect of EARLY administration of DEXamethasone in patients with COVID-19 pneumonia without acute hypoxemic respiratory failure and risk of development of acute respiratory distress syndrome (EARLY-DEX COVID-19): study protocol for a randomized controlled trial.

BACKGROUND: Corticosteroids are one of the few drugs that have shown a reduction in mortality in coronavirus disease 2019 (COVID-19). In the RECOVERY trial, the use of dexamethasone reduced 28-day mortality compared to standard care in hospitalized patients with suspected or confirmed COVID-19 requiring supplemental oxygen or invasive mechanical ventilation. Evidence has shown that 30% of COVID-19 patients with mild symptoms at presentation will progress to acute respiratory distress syndrome (ARDS), particularly patients in whom laboratory inflammatory biomarkers associated with COVID-19 disease progression are detected. We postulated that dexamethasone treatment in hospitalized patients with COVID-19 pneumonia without additional oxygen requirements and at risk of progressing to severe disease might lead to a decrease in the development of ARDS and thereby reduce death. METHODS/DESIGN: This is a multicenter, randomized, controlled, parallel, open-label trial testing dexamethasone in 252 adult patients with COVID-19 pneumonia who do not require supplementary oxygen on admission but are at risk factors for the development of ARDS. Risk for the development of ARDS is defined as levels of lactate dehydrogenase > 245 U/L, C-reactive protein > 100 mg/L, and lymphocyte count of < 0.80 × 109/L. Eligible patients will be randomly assigned to receive either dexamethasone or standard of care. Patients in the dexamethasone group will receive a dose of 6 mg once daily during 7 days. The primary outcome is a composite of the development of moderate or more severe ARDS and all-cause mortality during the 30-day period following enrolment. DISCUSSION: If our hypothesis is correct, the results of this study will provide additional insights into the management and progression of this specific subpopulation of patients with COVID-19 pneumonia without additional oxygen requirements and at risk of progressing to severe disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT04836780. Registered on 8 April 2021 as EARLY-DEX COVID-19.

Factors associated with in-hospital mortality and readmission in a cohort of patients treated with noninvasive ventilation during emergency department or out-of-hospital emergency care: the VentilaMadrid study. / Factores asociados a la mortalidad intrahospitalaria y reingreso en una cohorte tratada con ventilación no invasiva en urgencias extrahospitalarias y hospitalarias: estudio VentilaMadrid.

OBJECTIVES: To describe clinical, outcome, and risk factors in a cohort of patients treated with noninvasive ventilation (NIV) in a hospital emergency department (ED) or by out-of-hospital emergency medical services (OHEMSs). MATERIAL AND METHODS: Multicenter, prospective cohort study enrolling consecutive patients with acute pulmonary edema and/or exacerbated chronic obstructive pulmonary disease who were treated with NIV between November 2018 and November 2020 in a hospital ED or OHEMS setting in Madrid. We recorded baseline data, variables related to the acute episode, and outcome variables, including in-hospital mortality and 30-day readmission. RESULTS: A total of 317 patients were included; 132 (41.6%) were treated in an OHEMS setting and 185 (58.4%) in a hospital ED. Forty-seven (16.3%) in-hospital deaths occurred, and 78 patients (28.8%) were readmitted within 30 days. Mortality in the hospital ED and OHEMS subsamples did not differ, but the patients who received NIV in an OHEMS setting had a lower 30-day readmission rate. On multivariate analysis, in-hospital mortality was associated with prior dependence in activities of daily living in the multivariate analysis (odds ratio [OR], 2.4; 95% CI, 1.11-5.27) and a low-moderate score on the Simplified Acute Physiology Score II (SAPS II) versus a high-very high one (OR, 2.69; 95% CI, 1.26-5.77). Mortality after OHEMS ventilation was associated with discontinuance of NIV during transfer (OR, 8.57; 95% CI, 2.19-33.60). Readmission within 30 days was associated with group (in-hospital ED application of NIV) (OR, 3.24; 95% CI, 2.62-6.45) and prior dependence (OR, 2.08; 95% CI, 1.02-4.22). CONCLUSION: Patients treated in the hospital ED and OHEMS setting have similar baseline characteristics, although acute episodes were more serious in the OHEMS group. No significant differences were found related to in-hospital mortality. Higher mortality was associated with dependence, a SAPS II score greater than 52, and discontinuance of NIV. Readmission was associated with dependence and NIV treatment in the hospital ED setting.

OBJETIVO: Describir las características clínicas, evolutivas y los factores pronóstico de una cohorte de pacientes tratados con ventilación no invasiva (VNI) en servicios de urgencias extrahospitalarios (SUEH) y hospitalarios (SUH). METODO: Estudio de cohortes multicéntrico, prospectivo con inclusión consecutiva de pacientes con edema agudo de pulmón o agudización de enfermedad pulmonar obstructiva crónica tratados con VNI entre noviembre 2018 y noviembre de 2020 en SUEH y SUH de la Comunidad de Madrid. Se recogieron características basales, del episodio agudo, así como variables de resultado incluyendo la mortalidad hospitalaria y el reingreso a 30 días. RESULTADOS: Se incluyeron 317 pacientes, 132 (41,6%) en SUEH y 185 (58,4%) en SUH. Hubo 47 muertes intrahospitalarias (16,3%) y 78 reingresos a los 30 días (28,8%). No hubo diferencias en la mortalidad, pero el grupo VNI-SUEH tuvo menor reingreso a 30 días. En el análisis multivariado la mortalidad intrahospitalaria se asoció con la dependencia previa (OR = 2,4; IC 95%: 1,11-5,27) y el SAPS-II bajo-moderado frente al alto-muy alto (OR = 2,69; IC 95%: 1,26-5,77). En la cohorte extrahospitalaria, la mortalidad intrahospitalaria se asoció con la retirada de la VNI en la transferencia del paciente (OR = 8,57; IC 95%: 2,19-33,60). Los reingresos a los 30 días se asociaron con inicio de VNI en el hospital (OR = 3,24; IC 95%: 2,62-6,45) y dependencia previa (OR = 2,08; IC 95%: 1,02-4,22). CONCLUSIONES: Los pacientes de ambos grupos, SUH y SUEH, tienen un perfil clínico basal similar, aunque con mayor gravedad del episodio en el grupo SUEH. No se encontraron diferencias estadísticamente significativas en la mortalidad intrahospitalaria. Se asociaron a una mayor mortalidad la dependencia, la escala SAPS-II > 52 y la retirada de la VNI. El reingreso se asoció con la dependencia y pertenecer al grupo SUH.