Evaluación de las complicaciones clínicas de los pacientes con fractura de cadera y sus factores asociados en una Unidad de Agudos de Ortogeriatría / Assessment of clinical complications and their associated factors in hip-fracture patients in an Acute Geriatric Orthopaedic Unit

Introducción. Las complicaciones clínicas en pacientes con fractura de cadera (FC) son elevadas y variables por su heterogéneo registro. El objetivo del estudio fue evaluar las complicaciones clínicas y sus factores asociados en pacientes con FC ingresados en la Unidad de Ortogeriatría de un hospital universitario de 283 camas que atiende un promedio de 200 FC/año. Material y métodos. Se incluyó a 383 pacientes ingresados consecutivamente en 2013 y en 2014 en un estudio analítico observacional prospectivo. Las complicaciones clínicas se definieron según recomendaciones avaladas por la AOTrauma Network (Red de Trabajo de la Asociación Internacional de Traumatólogos para el estudio de la osteosíntesis). Resultados. Doscientos setenta y tres pacientes (71,28%) presentaron alguna complicación. Las principales fueron el delirium (55,4%), la insuficiencia renal (15,4%) y las complicaciones cardiacas (12,3%). Se asociaron a la presencia de alguna complicación la clasificación ASA III-IV (OR=1,962; IC del 95%, 1,040-3,704; p = 0,038), un índice de Barthel al alta inferior (b = -3,572;IC del 95%, -0,866 a -0,104; p = 0,01), el incremento en la estancia media (b = 2,683; IC del 95%, 3,522-0,325; p < 0,001) y preoperatoria (OR = 1,165; IC del 95%, 1,050-1,294; p = 0,004). Conclusiones. Las complicaciones clínicas más frecuentes son el delirium, la insuficiencia renal y las complicaciones cardiacas. Una puntuación en la escala de ASA III-IV, una peor situación funcional al alta, así como una estancia preoperatoria y media prolongada, son factores asociados a la presencia de alguna complicación clínica. Las complicaciones cardiacas, pulmonares y digestivas son las principales causas de mortalidad en la unidad

Introduction. The incidence of clinical complications in hip fracture (HF) patients is high and variable due to their heterogeneous nature. The aim of the study was to assess the clinical complications and their associated factors in HF patients admitted to the Orthopaedic Geriatric Unit of a 283 bed University Hospital. An average of 200 HF patients is attended yearly. Material and methods. A prospective, observational and analytical study was conducted on 383 consecutive patients admitted to the unit during the years 2013 and 2014. Clinical complications were defined according to recommendations supported by the AOTrauma Network (International Network of Traumatologists for the Study of Osteosynthesis). Results. A total of 273 patients (71.28%) showed some clinical complication. The main ones were, delirium (55.4%), renal failure (15.4%), and cardiac complications (12.3%). An ASA III-IV score of OR = 1.962 (95% CI; 1.040-3.704, P=.038), lower Barthel index at discharge (b = -3.572, 95% CI -0.866 to -0.104, P=.01), the increase in pre-operative stay (OR = 1.165, 95% CI 1.050-1.294, P=.004) and an increased length of stay (b = 2.663, 95% CI 3.522-0.325; P<.001) were factors associated with clinical complications. Conclusions. Delirium, renal failure, and cardiac complications were the most frequent complications according the new recommendations. An ASA III-IV score, worse functional status at discharge, prolonged pre-operative period, and increased length of stay, were risk factors associated with clinical complications. Cardiac, pulmonary, and gastrointestinal complications were the main causes of mortality in the unit

[Assessment of clinical complications and their associated factors in hip-fracture patients in an Acute Geriatric Orthopaedic Unit]. / Evaluación de las complicaciones clínicas de los pacientes con fractura de cadera y sus factores asociados en una Unidad de Agudos de Ortogeriatría.

INTRODUCTION: The incidence of clinical complications in hip fracture (HF) patients is high and variable due to their heterogeneous nature. The aim of the study was to assess the clinical complications and their associated factors in HF patients admitted to the Orthopaedic Geriatric Unit of a 283 bed University Hospital. An average of 200 HF patients is attended yearly. MATERIAL AND METHODS: A prospective, observational and analytical study was conducted on 383 consecutive patients admitted to the unit during the years 2013 and 2014. Clinical complications were defined according to recommendations supported by the AOTrauma Network (International Network of Traumatologists for the Study of Osteosynthesis). RESULTS: A total of 273 patients (71.28%) showed some clinical complication. The main ones were, delirium (55.4%), renal failure (15.4%), and cardiac complications (12.3%). An ASA III-IV score of OR = 1.962 (95% CI; 1.040-3.704, P=.038), lower Barthel index at discharge (b = -3.572, 95% CI -0.866 to -0.104, P=.01), the increase in pre-operative stay (OR = 1.165, 95% CI 1.050-1.294, P=.004) and an increased length of stay (b = 2.663, 95% CI 3.522-0.325; P<.001) were factors associated with clinical complications. CONCLUSIONS: Delirium, renal failure, and cardiac complications were the most frequent complications according the new recommendations. An ASA III-IV score, worse functional status at discharge, prolonged pre-operative period, and increased length of stay, were risk factors associated with clinical complications. Cardiac, pulmonary, and gastrointestinal complications were the main causes of mortality in the unit.

Hierro intravenoso, recuperación funcional y delirium en pacientes con fractura de cadera. Estudio FEDEREF. Ensayo clínico unicéntrico aleatorizado, controlado con placebo, doble ciego. Número EudraCT: 2014-001923-53 / Intravenous iron, functional recovery and delirium in patients with hip fracture. FEDEREF study. Single-centre randomised, placebo-controlled, and double-blind clinical trial. 2014-001923-53: EudraCT number

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)

[Intravenous iron, functional recovery and delirium in patients with hip fracture. FEDEREF study. Single-centre randomised, placebo-controlled, and double-blind clinical trial. 2014-001923-53: EudraCT number]. / Hierro intravenoso, recuperación funcional y delirium en pacientes con fractura de cadera. Estudio FEDEREF. Ensayo clínico unicéntrico aleatorizado, controlado con placebo, doble ciego. Número EudraCT: 2014-001923-53.

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.