RESUMO
Introducción. No existen estudios previos que evalúen el efecto de la ferroterapia intravenosa sobre la situación funcional y cognitiva de pacientes con fractura de cadera (FC). Material y métodos. Ensayo clínico unicéntrico aleatorizado, controlado con placebo, doble ciego en grupos paralelos, para comparar la eficacia del tratamiento con hierro intravenoso perioperatorio en pacientes ancianos intervenidos de FC. Se asegura el enmascaramiento del tratamiento, envolviendo el fármaco y el sistema de infusión. El grupo intervención recibirá, los días 1, 3 y 5 de ingreso, 200mg de Venofer (R ) (hierro sacarosa), diluidos en 100ml de suero salino y el control, 100ml de suero salino los días 1, 3 y 5 de ingreso. Los pacientes reciben la asistencia convencional en la Unidad de Ortogeriatría del Hospital Universitario Infanta Sofía. Para valorar el impacto del tratamiento, se recogen variables funcionales (actividades de la vida diaria y capacidad de deambulación), cognitivas (situación cognitiva previa y delirium), quirúrgicas, demográficas y clínicas durante el ingreso y se realiza un análisis de seguridad del tratamiento. Los pacientes reciben seguimiento a los 3, 6 y 12 meses. Resultados. El estudio reportará evidencia acerca del impacto de la administración de hierro intravenoso sobre la recuperación funcional a corto y medio plazo. Permitirá evaluar si la administración de ferroterapia intravenosa tiene algún efecto negativo sobre la incidencia de delirium postoperatorio. Aportará información acerca de la seguridad de la administración de ferroterapia intravenosa en pacientes ancianos con FC y su repercusión sobre el ahorro transfusional. Conclusiones. La inclusión de los pacientes ancianos con FC ingresados en una unidad de ortogeriatría en el ensayo clínico permitirá la evaluación del impacto del fármaco en un escenario habitual, y aportará datos valiosos para la protocolización de su uso en otras unidades (AU)
Introduction. There are no previous studies evaluating the effect of intravenous iron therapy on functional and cognitive status of patients with hip fracture (HF). Material and methods. A single-centre randomised, placebo-controlled, double-blind and parallel treatment, clinical trial has been designed to assess the efficacy of intravenous iron therapy during the peri-operative period in elderly patients suffering from a HF. Blinding will be ensured by the packaging of the drug infusion system. On days 1, 3, and 5 from admission, the intervention group will receive 200mg Venofer (R ) (iron sucrose) diluted in 100ml saline, and the control group 100ml saline, also on days 1, 3 and 5. Patients will received conventional treatment in ortho-geriatric unit of the Hospital Infanta Sofia. Functional variables (activities of daily living and walking), cognitive (cognitive status and delirium), surgical, demographic and clinical characteristics will be collected during admission in order to assess the impact of treatment. A safety analysis of the treatment will also performed. Patients will be followed-up at 3, 6, and 12 months. Results. The study will attempt to provide evidence on the impact of the intravenous iron administration on functional recovery. It will be determined whether iron therapy negatively affects the incidence of post-operative delirium. Finally, report will be presented on the safety data of intravenous iron in elderly HF patients, as well as the impact on allogenic blood transfusion savings. Conclusions. The inclusion of elderly HF patients admitted to an ortho-geriatric unit, in a clinical trial, will help to improve the knowledge of the treatment impact on a usual scenario, and provide useful data for use in other units (AU)
Assuntos
Humanos , Idoso , Ferro/administração & dosagem , Delírio/induzido quimicamente , Fraturas do Quadril/terapia , Administração Intravenosa , Recuperação de Função Fisiológica , Placebos/uso terapêutico , Transfusão de Sangue , Complicações Pós-Operatórias/prevenção & controle , Ferro/efeitos adversosRESUMO
INTRODUCTION: There are no previous studies evaluating the effect of intravenous iron therapy on functional and cognitive status of patients with hip fracture (HF). MATERIAL AND METHODS: A single-centre randomised, placebo-controlled, double-blind and parallel treatment, clinical trial has been designed to assess the efficacy of intravenous iron therapy during the peri-operative period in elderly patients suffering from a HF. Blinding will be ensured by the packaging of the drug infusion system. On days 1, 3, and 5 from admission, the intervention group will receive 200mg Venofer® (iron sucrose) diluted in 100ml saline, and the control group 100ml saline, also on days 1, 3 and 5. Patients will received conventional treatment in ortho-geriatric unit of the Hospital Infanta Sofia. Functional variables (activities of daily living and walking), cognitive (cognitive status and delirium), surgical, demographic and clinical characteristics will be collected during admission in order to assess the impact of treatment. A safety analysis of the treatment will also performed. Patients will be followed-up at 3, 6, and 12 months. RESULTS: The study will attempt to provide evidence on the impact of the intravenous iron administration on functional recovery. It will be determined whether iron therapy negatively affects the incidence of post-operative delirium. Finally, report will be presented on the safety data of intravenous iron in elderly HF patients, as well as the impact on allogenic blood transfusion savings. CONCLUSIONS: The inclusion of elderly HF patients admitted to an ortho-geriatric unit, in a clinical trial, will help to improve the knowledge of the treatment impact on a usual scenario, and provide useful data for use in other units.
