SepsisJEDI-2NCT06613256
Characterisation of Endothelial Cells in Different Inflammatory Pathologies
An observational study of Sepsis and Vasoplegia, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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?' Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Vasoplegia
- What is being tested?
- Endothelial cell biopsy
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jul 2024to 12 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy volunteer
- Adult ≥ 18 years
- Able and willing to give consent
- Surgical patients
- Adult ≥ 18 years
- Patients admitted to RSFT for planned major surgery
Show all 10Show fewer
- Critically ill patients
- Adult ≥ 18 years
- Emergency admission to ICU at RSFT
- Meets the sepsis 3.0 definition
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Surrey NHS Foundation Trust
Guildford, Surrey, GU27XX
Ben Creagh-Brown, BM, PhD, +44 (0)1483 688 660, bencb@nhs.net
Charlie Piercy, MSc, +44 (0)1483 688 660, Charles.piercy@nhs.net
About this study
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?'
Read the detailed description
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.
- Conditions
- Sepsis, Vasoplegia
- Being tested
- Endothelial cell biopsy
- Medical subject headings
- Sepsis, Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelial cell biopsyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - control patients | 25 healthy volunteers
1 X Endothelial cell biopsy Receives: 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 Receives: Other: Endothelial cell biopsy | |
| Part 1 - sepsis patients | 20 sepsis patients
1 X Endothelial cell biopsy
Samples collected on admission to ICU Receives: 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 Receives: 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 Receives: Other: Endothelial cell biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start16 Jul 2024
- Primary completion17 Jul 2026 (estimated)
- Study completion12 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613256
- Sponsor's protocol ID
- 24SURN320251
- Acronym
- JEDI-2
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Endothelial Cells in Different Inflammatory Pathologies
- ClinicalTrials.gov ID
- NCT06613256
- Acronym / sponsor ID
- JEDI-2 / 24SURN320251
- Conditions
- Sepsis, Vasoplegia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Surrey
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 17 Jul 2026 (estimated)
- Study completion
- 12 Nov 2026 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?'
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 - control patients | – | Other: Endothelial cell biopsy25 healthy volunteers 1 X Endothelial cell biopsy |
| Part 1 - surgical patients | – | Other: Endothelial cell biopsy20 surgical patients 1 X Endothelial cell biopsy Samples collected at 24 hours post knife to skin to capture peak inflammation |
| Part 1 - sepsis patients | – | Other: Endothelial cell biopsy20 sepsis patients 1 X Endothelial cell biopsy Samples collected on admission to ICU |
| Part 2 - surgical patients | – | Other: Endothelial cell biopsy20 surgical patients 3 X Endothelial cell biopsy Samples collected pre-surgery, 24 hours and 48 hours post knife to skin |
| Part 2 - sepsis patients | – | Other: Endothelial cell biopsy20 sepsis patients 3 X Endothelial cell biopsy Samples collected on admission, 24 hours and 48 hours post admission to ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Healthy volunteer
- Adult ≥ 18 years
- Able and willing to give consent
- Surgical patients
- Adult ≥ 18 years
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endothelial cell biopsyEndothelial 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 | Other | Part 1 - control patients, Part 1 - sepsis patients, Part 1 - surgical patients, Part 2 - sepsis patients, Part 2 - surgical patients |
Primary outcome
Differential gene expression in endothelial cells
Time frame: 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Sepsis
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Not yet recruiting
Personalized Metabolic Nutrition Sepsis Study
Pediatric Sepsis
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Vasoplegia, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ben Creagh-Brown, BM, PhD (+44 (0)1483 688 660, bencb@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential gene expression in endothelial cells (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.