JEDI-2Endothelial Cells in Inflammatory Conditions
Data Collection
Collected from today forward - ProspectiveCardiovascular Diseases+7
+ Infections
+ Inflammation
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: July 16, 2024
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.105 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Royal Surrey NHS Foundation Trust
Guildford, United KingdomOpen Royal Surrey NHS Foundation Trust in Google Maps