Sepsis in the ICU-II

UPDATE 26 Feb 2022: A pilot project was completedafter recruitment of 50 patients confirming the feasibility of data collection, study logistics, biomarker assay set-up and frequency of outcomes. Cancellation of non-COVID related research in 2020\&2021 has caused significant delays. Recruitment of patients will continue during 2022\&2023. At the time of writing 70 patients have been recruited across 4 centres. UPDATE 15 Mar 2026: At the steering committee meeting on 12 August 2024, the principal investigator presented population characteristics of the first 49 patients in the feasibility phase and compared them with the subsequent 231 recruited patients. The two cohorts were similar in age and sex, but the later cohort had higher median SAPS II scores, greater use of organ support, and higher ICU and 30-day mortality. Discussions with recruiting sites indicated that the COVID-19 pandemic had substantially changed the case-mix of ICU admissions; nursing staff shortages and bed closures led to admission of more severely ill patients, particularly at the major recruiting site. The steering committee concluded that there was no need to deviate from the original protocol but recommended recruitment of an additional 49 patients to reduce potential heterogeneity in the underlying population. The total target sample size was therefore set at 379 patients. The expanded sample size was approved by the Swedish Ethical Review Authority on 7 Feb 2025.