MIS-ABC Sepsis: Mechanistic Inflammatory Sub-study embedded in the Albumin versus Balanced Crystalloid in Sepsis trial – ABC Sepsis
We are conducting a sub-study, a separate but linked part of the main study, called ABC Sepsis.
Our sub-study, called MIS-ABC sepsis, aims to take blood samples from some of the participants in the main trial to examine the immune system’s response to sepsis and the treatments we give for sepsis. There are two main objectives of the sub-study: the first is to see if we can explain whether using one type of fluid over the other changes the immune response; and the second is whether the changes in the immune system can predict how unwell people get with sepsis. In essence, the main trial will give us an idea of what fluid is better, but the sub-study will help us understand why.
The sub-study is entirely optional for participants in the main trial. We hope to recruit at least 30 participants from each group in the main trial, and wouldn’t recruit more than 80 participants in total. For those enrolled in the trial, we will take blood samples at three points during the first day or so of their hospital admission. These will occur at:
- Baseline: at enrolment (0hr)
- Second sample: 12 hours after enrolment (±4hrs)
- Last sample: 24 hours after enrolment (±6hrs)
At each time point, two blood tubes are taken from a vein.
The samples we take will be analysed at the end of the study by our central laboratory in the University of Edinburgh. This includes cellular phenotyping (identifying how many and what type of immune cells we can see in the blood), a cytokine panel (measuring important inflammatory signalling molecules in the blood), and RNA transcriptomics (genetic analysis of the immune response).