At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Endothelial cell biopsy (other)
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- Endothelial cell biopsy — other: Endothelial cell sample collected from the antecubital fossa of patients.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 105
- Started
- 2024-07-16
- Last checked
- 2024-09
Plain English Summary
What is this study?
- • Testing a new treatment for sepsis
- • Clinical study - 105 participants
- • The goal of this observational study is to characterise changes in gene expression in endothelial cells in patients with either sepsis or post major abdominal surgery
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with sepsis
Where?
- • Guildford - Royal Surrey NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this observational study is to characterise changes in gene expression in endothelial cells in patients with either sepsis or post major abdominal surgery. The main question we plan to answer is: 'What molecular pathways are differentially expressed during inflammatory pathologies?'
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Healthy volunteer
- ✓Adult ≥ 18 years
- ✓Able and willing to give consent
- ✓Surgical patients
- ✓Patients admitted to RSFT for planned major surgery
Who cannot take part
- ✗Healthy volunteer
- ✗Not currently a patient within the hospital
- ✗Absence of inflammatory diseases and disorders including but not limited to arthritis, peripheral artery disease,...
- ✗Not on immunomodulatory medications, such as corticosteroids
- ✗History of recent major trauma within the last 2 months (e.g., surgery or injury requiring hospitalisation)
See the full criteria
Where Is This Study? (1 UK site)
Royal Surrey NHS Foundation Trust
Guildford GU27XX, United Kingdom
How to Get in Touch
Ben Creagh-Brown, BM, PhD
Sponsor contactCONTACT
Charlie Piercy, MSc
Sponsor contactCONTACT