Characterisation of Endothelial Cells in Different Inflammatory Pathologies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Surrey County Hospital NHS Foundation Trust
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?'
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult ≥ 18 years
Able and willing to give consent
Adult ≥ 18 years
Patients admitted to RSFT for planned major surgery
Disqualifiers
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)
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endothelial cell biopsy
Other interventionEndothelial 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
Treatment groups
105 Participants
are divided into 5 treatment groupsGroup A: Part 1 - control patients1 intervention
Group B: Part 1 - surgical patients1 intervention
Group C: Part 1 - sepsis patients1 intervention
Group D: Part 2 - surgical patients1 intervention
Group E: Part 2 - sepsis patients1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSponsors and contacts
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Royal Surrey County Hospital NHS Foundation Trust
Lead sponsor
University of Surrey
Collaborator
Source ClinicalTrials.gov