JEDI-2Cellules endothéliales dans des conditions inflammatoires
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveMaladies Cardiovasculaires+7
+ Infections
+ Inflammation
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 16 juillet 2024
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.105 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Royal Surrey NHS Foundation Trust
Guildford, United KingdomOuvrir Royal Surrey NHS Foundation Trust dans Google Maps