JEDI-2Células endoteliales en condiciones inflamatorias
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades Cardiovasculares+4
+ Inflamación
+ Infecciones
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 16 de julio de 2024
Fecha en la que se inscribió al primer participante.The immune system is a complex network of cells and molecules that protects the body from infection and injury. When the immune system is activated, it produces inflammation, which is a natural response to help heal the body. However, too much inflammation can be harmful and lead to serious complications, such as sepsis, low blood pressure, organ failure and death. The interaction of cells that line the blood vessels (endothelial cells, EC) with the immune system, is believed to be the root cause of these symptoms. When exposed to inflammation, the instructional molecules (RNA) inside the EC change. This leads to a change of operation promoting the severe symptoms previously mentioned. Researchers have developed new safe techniques to collect these cells from the blood vessels of patients to study disorders like diabetes, heart disease and stroke. This technique involves gently inserting a metal guidewire into an arm vein to collect ECs. This study plans to collect ECs from patients undergoing surgery or admitted to intensive care. We also plan to collect control samples from healthy volunteers. Samples will be collected over the duration of the patients to RSFT. The RNA will be removed from the cells and counted to highlight changes in instructions in the cells. Data from this study will potentially highlight new pathways involved in inflammation and help classify how some patients will react to current treatments. To obtain this data, this study will be split into 2 parts. Part 1 focuses on collecting one sample from a patient when they are at their most unwell states and comparing that to a sample from a healthy person. Part 2 will focus on key mRNA molecules identified during Part 1 and identifying how their expression changes over time.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 105 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Healthy volunteer * Adult ≥ 18 years * Able and willing to give consent Surgical patients * Adult ≥ 18 years * Patients admitted to RSFT for planned major surgery Critically ill patients * Adult ≥ 18 years * Emergency admission to ICU at RSFT * Meets the sepsis 3.0 definition Exclusion Criteria: Healthy volunteer * Not currently a patient within the hospital * Absence of inflammatory diseases and disorders including but not limited to arthritis, peripheral artery disease, vasculitis, diabetes, cardiovascular disease and CKD. * Not on immunomodulatory medications, such as corticosteroids * History of recent major trauma within the last 2 months (e.g., surgery or injury requiring hospitalisation) Surgical patients * Patients with restricted liberty, prisoners or under legal protection * Anticipated prohibitively difficult venous cannulation * Presenting with inflammatory diseases and disorders including but not limited to arthritis, peripheral artery disease, vasculitis, sepsis, diabetes with end organ damage, cardiovascular disease and CKD * Currently prescribed immunomodulatory medication or immunocompromised * Received chemotherapy within 2 weeks of predicted sampling * Receiving vasopressor support prior to surgery * History of recent major trauma within the last 2 months (e.g., surgery or injury requiring hospitalisation) Critically ill patients * Patients with restricted liberty, prisoners or under legal protection• Anticipated prohibitively difficult venous cannulation * Presenting with inflammatory diseases and disorders including but not limited to arthritis, peripheral artery disease, vasculitis, diabetes with end organ damage, cardiovascular disease and CKD. * Currently prescribed immunomodulatory medication or immunocompromised * Received chemotherapy within 2 weeks of predicted sampling. * History of recent major trauma within the last 2 months (e.g., surgery or injury requiring hospitalisation)
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Royal Surrey NHS Foundation Trust
Guildford, United KingdomAbrir Royal Surrey NHS Foundation Trust en Google Maps