SepsisMIS-ABC SepsisNCT04963569
Mechanistic Inflammatory Sub-study Embedded Within the Albumin vs Balanced Crystalloid Trial
An observational study of Sepsis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
MIS-ABC Sepsis is a sub-study looking to understand how the immune response in patients with infection changes during the early stages of the illness, as well as after intravenous fluid treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Dec 2021to 8 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals presenting to the Emergency Department, Acute Medical Unit or Surgical Admission Unit.
Who may be able to join
- Able to obtain informed consent
- Eligible for and randomised into the ABC Sepsis trial
Who cannot join
- Excluded from the ABC Sepsis trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SA
About this study
MIS-ABC Sepsis is a sub-study looking to understand how the immune response in patients with infection changes during the early stages of the illness, as well as after intravenous fluid treatment. Participants in the main trial will be given one of two types of fluid (Human Albumin Solution (HAS) and Balanced Crystalloid) via a drip when they present to the hospital with severe infection (sepsis). The main trial is assessing which fluid is better, and we are going to take three blood samples around the time people come to hospital to see what happens to their immune system as a result of the infection and fluid treatment. We hope our findings will explain why one fluid might be better than another. It may also give us an important information about whether we can predict which people might get sicker despite treatment.
Read the detailed description
MIS-ABC Sepsis is linked to the ABC-Sepsis trial, a pilot feasibility trial recruiting patients with community acquired infection/sepsis with a NEWS2 score of five or more and randomising the participants to receiving either balanced crystalloid or 5% HAS as the intravenous resuscitation fluid up to six hours after randomisation.
MIS-ABC Sepsis will take serial blood samples from a small number of these participants, at hospital presentation and at two further points early during the patient's admission, to allow analysis of how inflammation changes during their course of illness. Investigating temporal change and differences between treatment arms of the main study will allow a nuanced analysis of the interplay between severity of illness, physiological changes over time and any potential differences between fluid treatment arm.
This is a prospective observational study enrolling patients randomised to the ABC Sepsis study. Centres for this trial will be selected from UK NHS hospitals who are recruiting to the main ABC Sepsis study. Participants will be recruited as soon as possible, and up to 12 hours after presentation to the Emergency Department, Surgical Assessment Unit or Medical Admissions Unit.
The treatment phase of the main study spans 6 hours following randomisation, with the follow up period extending to 90 days. This sub-study requires three blood samples: immediately after enrolment, at approximately 12 and 24 hours thereafter. The follow up period similarly extends to 90 days, using routine data from the medical records for follow up.
- Conditions
- Sepsis
- Keywords
- sepsis, infection, inflammation, cytokine, interleukin, intravenous, fluids, resuscitation, albumin, crystalloid
- Medical subject headings
- Sepsis, Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Albumin | Participants enrolled in the ABC Sepsis trial who have been randomised to 5% Human Albumin Solution as the sole resuscitative fluid in the first 6 hours. | |
| Balanced Crystalloid | Participants enrolled in the ABC Sepsis trial who have been randomised to Balanced Crystalloid as the sole resuscitative fluid in the first 6 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis.
Exploratory analysis to map mechanistic inflammatory response over time: 0, 12 and 24 hours. As the analysis is exploratory, there is no defined limit to cell types or cytokines measured.
Cytokines measured: tumour necrosis factor alpha (TNF-alpha), interleukin 6 (IL-6), granulocyte-macrophage colony-stimulating factor (GM-CSF), C-X-C motif chemokine ligand 10 (CXCL10), interleukin 5 (IL-5), interferon alpha 2 (IFN-a2), interleukin 4 (IL-4), C-C motif chemokine ligand 3 (CCL3), interleukin 10 (IL-10), interleukin 12p70 (IL-12p70), C-C motif chemokine ligand 20 (CCL20), interferon gamma (IFN-gamma), C-X-C motif chemokine ligand 8 (CXCL8), and C-C motif chemokine 4(CCL4).
This outcome measure describes the number of participants who were eligible for inclusion in the exploratory analysis described above and in later outcomes.
Units: number of participants eligible for inclusion in comparison.
Measured: At presentation, 12 and 24 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at Presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Measured: 24 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at Presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Measured: 24 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Measured: 24 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Measured: 24 hours from presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Measured: 24 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Measured: 24 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 24 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours from presentation.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Measured: 24 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Measured: 24 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Measured: 24 hours from baseline
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from baseline
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Measured: 24 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at Presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours
Measured: 24 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 24 hours from baseline
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 0 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 0 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 12 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Measured: 12 hours from presentation
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 24 Hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Measured: 24 hours from presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start13 Dec 2021
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, Royal College of Emergency Medicine
- Responsible party
- Sponsor
- Investigators
- Alasdair Gray, MD, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963569
- Sponsor's protocol ID
- AC21050
- Other IDs
- G/2021/1, 301333, 300332
- Acronym
- MIS-ABC Sepsis
- Status last verified
- Apr 2025
- First submitted
- 10 Jun 2021
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share study day according to the FAIR principles, after agreement with the study sponsor policies.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Inflammatory Sub-study Embedded Within the Albumin vs Balanced Crystalloid Trial
- ClinicalTrials.gov ID
- NCT04963569
- Acronym / sponsor ID
- MIS-ABC Sepsis / AC21050
- Conditions
- Sepsis
- Keywords
- sepsis, infection, inflammation, cytokine, interleukin, intravenous, fluids, resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, Royal College of Emergency Medicine
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MIS-ABC Sepsis is a sub-study looking to understand how the immune response in patients with infection changes during the early stages of the illness, as well as after intravenous fluid treatment. Participants in the main trial will be given one of two types of fluid (Human Albumin Solution (HAS) and Balanced Crystalloid) via a drip when they present to the hospital with severe infection (sepsis). The main trial is assessing which fluid is better, and we are going to take three blood samples around the time people come to hospital to see what happens to their immune system as a result of the infection and fluid treatment. We hope our findings will explain why one fluid might be better than another. It may also give us an important information about whether we can predict which people might get sicker despite treatment.
Detailed description
MIS-ABC Sepsis is linked to the ABC-Sepsis trial, a pilot feasibility trial recruiting patients with community acquired infection/sepsis with a NEWS2 score of five or more and randomising the participants to receiving either balanced crystalloid or 5% HAS as the intravenous resuscitation fluid up to six hours after randomisation.
MIS-ABC Sepsis will take serial blood samples from a small number of these participants, at hospital presentation and at two further points early during the patient's admission, to allow analysis of how inflammation changes during their course of illness. Investigating temporal change and differences between treatment arms of the main study will allow a nuanced analysis of the interplay between severity of illness, physiological changes over time and any potential differences between fluid treatment arm.
This is a prospective observational study enrolling patients randomised to the ABC Sepsis study. Centres for this trial will be selected from UK NHS hospitals who are recruiting to the main ABC Sepsis study. Participants will be recruited as soon as possible, and up to 12 hours after presentation to the Emergency Department, Surgical Assessment Unit or Medical Admissions Unit.
The treatment phase of the main study spans 6 hours following randomisation, with the follow up period extending to 90 days. This sub-study requires three blood samples: immediately after enrolment, at approximately 12 and 24 hours thereafter. The follow up period similarly extends to 90 days, using routine data from the medical records for follow up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin | – | –Participants enrolled in the ABC Sepsis trial who have been randomised to 5% Human Albumin Solution as the sole resuscitative fluid in the first 6 hours. |
| Balanced Crystalloid | – | –Participants enrolled in the ABC Sepsis trial who have been randomised to Balanced Crystalloid as the sole resuscitative fluid in the first 6 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals presenting to the Emergency Department, Acute Medical Unit or Surgical Admission Unit.
Key inclusion criteria (2 listed)
- Able to obtain informed consent
- Eligible for and randomised into the ABC Sepsis trial
Key exclusion criteria (1 listed)
- Excluded from the ABC Sepsis trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis.
Time frame: At presentation, 12 and 24 hours.
Exploratory analysis to map mechanistic inflammatory response over time: 0, 12 and 24 hours. As the analysis is exploratory, there is no defined limit to cell types or cytokines measured. Cytokines measured: tumour necrosis factor alpha (TNF-alpha), interleukin 6 (IL-6), granulocyte-macrophage colony-stimulating factor (GM-CSF), C-X-C motif chemokine ligand 10 (CXCL10), interleukin 5 (IL-5), interferon alpha 2 (IFN-a2), interleukin 4 (IL-4), C-C motif chemokine ligand 3 (CCL3), interleukin 10 (IL-10), interleukin 12p70 (IL-12p70), C-C motif chemokine ligand 20 (CCL20), interferon gamma (IFN-gamma), C-X-C motif chemokine ligand 8 (CXCL8), and C-C motif chemokine 4(CCL4). This outcome measure describes the number of participants who were eligible for inclusion in the exploratory analysis described above and in later outcomes. Units: number of participants eligible for inclusion in comparison.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at Presentation
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 24 Hours
Time frame: 24 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at Presentation
Time frame: 0 hours
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 24 Hours
Time frame: 24 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 0 Hours
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 24 Hours
Time frame: 24 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 0 Hours
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 24 Hours
Time frame: 24 hours from presentation.
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 0 Hours
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 24 Hours
Time frame: 24 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 0 Hours
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 24 Hours
Time frame: 24 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 0 Hours
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 24 Hours
Time frame: 24 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 0 Hours
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours from presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 24 Hours
Time frame: 24 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 0 Hours
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 24 Hours
Time frame: 24 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 0 Hours
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 24 Hours
Time frame: 24 hours from baseline
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 0 Hours
Time frame: 0 hours from baseline
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 24 Hours
Time frame: 24 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at Presentation
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at 0 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at 24 Hours
Time frame: 24 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 0 Hours
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 24 Hours
Time frame: 24 hours from baseline
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 0 Hours
Time frame: 0 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 12 Hours
Time frame: 12 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 24 Hours
Time frame: 24 hours from presentation
Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ABC Sepsis Trial RegistrationLink provided by the sponsor.
- Study WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We plan to share study day according to the FAIR principles, after agreement with the study sponsor policies.
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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. This study is not recruiting at the moment.
Alasdair Gray, MD study director
University of Edinburgh
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, run by University of Edinburgh 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 15 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. (time frame: At presentation, 12 and 24 hours.). The study lists 43 primary outcomes in all. 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 15 Apr 2025.