Characterisation of Endothelial Cells in Different Inflammatory Pathologies

NCT06613256 | Recruiting

• 1 other identifier: 24SURN320251
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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?'

Conditions

Sepsis; Vasoplegia

Outcome Measures

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.

  2 years

Study Arms (5)

Part 1 - control patients

25 healthy volunteers 1 X Endothelial cell biopsy

Other: Endothelial cell biopsy

Part 1 - surgical patients

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

Part 1 - sepsis patients

20 sepsis patients 1 X Endothelial cell biopsy Samples collected on admission to ICU

Other: Endothelial cell biopsy

Part 2 - surgical patients

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

Part 2 - sepsis patients

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

Interventions

Endothelial cell biopsy OTHER

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

Part 1 - control patients; Part 1 - sepsis patients; Part 1 - surgical patients; Part 2 - sepsis patients; Part 2 - surgical patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead
• University of Surrey: collaborator

Study Sites (1)

Royal Surrey NHS Foundation Trust

Guildford, Surrey, GU27XX, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. RNA extracted from endothelial cell biopsies 2. Serum and plasma from paired blood samples

MeSH Terms

Conditions

Sepsis; Vasoplegia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications

Central Study Contacts

Ben Creagh-Brown, BM, PhD

CONTACT

+44 (0)1483 688 660; bencb@nhs.net

Charlie Piercy, MSc

CONTACT

+44 (0)1483 688 660; charles.piercy@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 25, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): July 17, 2026
• Study Completion (Estimated): November 12, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)