N/A
N=26
Mechanistic Inflammatory Sub-study Embedded Within the Albumin vs Balanced Crystalloid Trial
Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT04963569 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. — 14; 12 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Edinburgh
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. |
14; 12 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at Presentation |
18.3; 8.7 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 12 Hours |
15.4; 6.6 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 24 Hours |
16.5; 7.3 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at Presentation |
9.9; 4.5 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 12 Hours |
7.2; 2.8 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 24 Hours |
7.7; 3.1 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 0 Hours |
2017.9; 2513.3 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 12 Hours |
492.0; 305.6 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 24 Hours |
119.0; 52.3 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 0 Hours |
453.1; 1073.3 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 12 Hours |
816.6; 846.1 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 24 Hours |
450.7; 324.4 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 0 Hours |
5.8; 15.6 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 12 Hours |
4.9; 18.4 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 24 Hours |
5.0; 2.4 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 0 Hours |
16.6; 5.6 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 12 Hours |
12.3; 4.2 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 24 Hours |
11.0; 4.0 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 0 Hours |
19.5; 9.0 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 12 Hours |
14.6; 5.5 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 24 Hours |
14.4; 7.1 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 0 Hours |
127.2; 55.5 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 12 Hours |
95.7; 48.5 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 24 Hours |
98.0; 35.1 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 0 Hours |
748.1; 715.3 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 12 Hours |
620.8; 47.2 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 24 Hours |
362.8; 5.3 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 0 Hours |
24.2; 6.4 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 12 Hours |
34.8; 3.9 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 24 Hours |
11.4; 3.0 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 0 Hours |
1792.5; 708.2 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 12 Hours |
555.4; 659.3 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 24 Hours |
314.1; 276.7 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at Presentation |
172.1; 31.2 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at 0 Hours |
114.3; 29.8 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at 24 Hours |
99.7; 27.0 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 0 Hours |
203.3; 149.5 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 12 Hours |
114.4; 70.9 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 24 Hours |
88.3; 39.4 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 0 Hours |
11.0; 19.6 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 12 Hours |
6.8; 13.6 | — |
| PRIMARY Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 24 Hours |
6.1; 9.8 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- Able to obtain informed consent
- Eligible for and randomised into the ABC Sepsis trial
Exclusion Criteria
- Excluded from the ABC Sepsis trial
Data sourced from ClinicalTrials.gov (NCT04963569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.