New-onset septic shock in the ImmunoSep trial By Ruyuan Zhang April 2, 2026 0 min Critical Care (Springer) Share Summary Takeaways Listen Insight Report Clinical Scorecard Quiz Poll Top Institutions 1 The ImmunoSep trial demonstrated that biomarker-guided immunotherapy improved organ dysfunction in sepsis patients compared to placebo. 2 Septic shock occurred in 22.1% of patients receiving immunotherapy versus 11.7% in the placebo group, indicating a potential increased risk. 3 The observed differences in septic shock incidence should be interpreted cautiously due to small event counts and statistical fragility. 4 Mechanistically, the increased septic shock incidence may result from immune dysregulation or treatment-related changes in host response. 5 Safety analyses in randomized trials are descriptive, and new-onset septic shock may reflect disease trajectory rather than drug toxicity.