RESUMEN
BACKGROUND: Elafin is a potent endogenous neutrophil elastase inhibitor that protects against myocardial inflammation and injury in preclinical models of ischaemic-reperfusion injury. We investigated whether elafin could inhibit myocardial ischaemia-reperfusion injury induced during coronary artery bypass graft (CABG) surgery. METHODS AND RESULTS: In a randomised double-blind placebo-controlled parallel group clinical trial, 87 patients undergoing CABG surgery were randomised 1:1 to intravenous elafin 200â mg or saline placebo administered after induction of anaesthesia and prior to sternotomy. Myocardial injury was measured as cardiac troponin I release over 48â h (area under the curve (AUC)) and myocardial infarction identified with MRI. Postischaemic inflammation was measured by plasma markers including AUC high-sensitive C reactive protein (hs-CRP) and myeloperoxidase (MPO). Elafin infusion was safe and resulted in >3000-fold increase in plasma elafin concentrations and >50% inhibition of elastase activity in the first 24â h. This did not reduce myocardial injury over 48â h (ratio of geometric means (elafin/placebo) of AUC troponin I 0.74 (95% CI 0.47 to 1.15, p=0.18)) although post hoc analysis of the high-sensitive assay revealed lower troponin I concentrations at 6â h in elafin-treated patients (median 2.4 vs 4.1â µg/L, p=0.035). Elafin had no effect on myocardial infarction (elafin, 7/34 vs placebo, 5/35 patients) or on markers of inflammation: mean differences for AUC hs-CRP of 499â mg/L/48 h (95% CI -207 to 1205, p=0.16), and AUC MPO of 238â ng/mL/48 h (95% CI -235 to 711, p=0.320). CONCLUSIONS: There was no strong evidence that neutrophil elastase inhibition with a single-dose elafin treatment reduced myocardial injury and inflammation following CABG-induced ischaemia-reperfusion injury. TRIAL REGISTRATION NUMBER: (EudraCT 2010-019527-58, ISRCTN82061264).
Asunto(s)
Puente de Arteria Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/cirugía , Elafina/administración & dosificación , Complicaciones Intraoperatorias/tratamiento farmacológico , Daño por Reperfusión Miocárdica/tratamiento farmacológico , Método Doble Ciego , Estudios de Seguimiento , Humanos , Infusiones Intravenosas , Complicaciones Intraoperatorias/etiología , Periodo Intraoperatorio , Imagen por Resonancia Cinemagnética , Daño por Reperfusión Miocárdica/diagnóstico , Daño por Reperfusión Miocárdica/etiología , Inhibidores de Proteasas/administración & dosificación , Proteínas Recombinantes , Estudios RetrospectivosAsunto(s)
Bases de Datos Factuales , Docentes de Enfermería , Servicios de Información/organización & administración , Internet/organización & administración , Relaciones Interprofesionales , Enfermeras Administradoras , Personal de Enfermería/educación , Personal de Enfermería/provisión & distribución , Comunicación , Empleo , Predicción , Humanos , Kansas , Liderazgo , Modelos de Enfermería , Enfermeras Administradoras/psicología , Personal de Enfermería/tendencias , Objetivos Organizacionales , Evaluación de Programas y Proyectos de SaludAsunto(s)
Federación para Atención de Salud , Internet , Enfermería , Redes Comunitarias , Bases de Datos como Asunto , Educación en Enfermería , Empleo , Humanos , Missouri , Enfermeras Administradoras , Enfermería/organización & administración , Sociedades de Enfermería , Desarrollo de Personal , Recursos HumanosRESUMEN
The purposes of this qualitative study were to describe behaviors of infants and toddlers when in acute pain and to describe changes in those behaviors across the 3-yr span. With the use of naturalistic observation, 32 children, birth to 36 mo of age, were observed following surgery, fractures, or burns. Purposeful sampling of children, who were inpatients of a private midwestern hospital, was used. Data sources included child observations, parent interviews, and patient records. The research method used was grounded theory. Three pain behavior categories were developed, and characteristics of each category were identified. Pain categories included motor movement, communication, and facial expression. Theoretic implications were proposed. It is concluded that predictable changes in pain behaviors occur within infancy and toddlerhood. A matrix of pain behavior is presented.