An observational study in Sepsis and Vasoplegia, sponsored by Royal Surrey County Hospital NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Royal Surrey County Hospital NHS Foundation Trust · Observational
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?'
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 105 is below the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Royal Surrey County Hospital NHS Foundation Trust is the lead sponsor of 35 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Surgical cohort This cohort will predominantly be made up predominantly of patients undergoing major abdominal surgery (HPB, Gynae Onc and Colorectal) requiring recovery in ICU as part of their cancer treatment.
Critically unwell cohort This cohort will be made up of emergency admissions to ICU for patients requiring additional organ support.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy volunteer
Surgical patients
Critically ill patients
Exclusion Criteria:
Healthy volunteer
Surgical patients
Critically ill patients
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
25 healthy volunteers 1 X Endothelial cell biopsy
Other: Endothelial cell biopsy
20 surgical patients 1 X Endothelial cell biopsy Samples collected at 24 hours post knife to skin to capture peak inflammation
Other: Endothelial cell biopsy
20 sepsis patients 1 X Endothelial cell biopsy Samples collected on admission to ICU
Other: Endothelial cell biopsy
20 surgical patients 3 X Endothelial cell biopsy Samples collected pre-surgery, 24 hours and 48 hours post knife to skin
Other: Endothelial cell biopsy
20 sepsis patients 3 X Endothelial cell biopsy Samples collected on admission, 24 hours and 48 hours post admission to ICU
Other: Endothelial cell biopsy
Endothelial cell sample collected from the antecubital fossa of patients. A vein in the antecubital fossa is cannulated with a 20 g valveless cannula. A metal guidewire is then passed into the vessel to collect endothelial cells for analysis
Differential gene expression in endothelial cells
Using RNA extracted from the two patient cohorts and controls in part 1, we plan to use RNA-SEQ to identify differentially expressed genes. Once we have identified genes we believe to be critically involved with endothelial dysfunction, we will then perform serial sampling on an additional two groups of patients and using qRT-PCR to analyse gene expression changes.
Time frame: 2 years
Plan to share: No
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Royal Surrey County Hospital NHS Foundation Trust