Polymyxin B haemoadsorption in endotoxic septic shock (Tigris): a multicentre, open-label, Bayesian, randomised, controlled, phase 3 trial
Primary result · 28-day mortalityResult — go to the resultAPACHE-II adjusted OR 0.67 95% CrI 0.39–1.08Authors' conclusion
In patients with endotoxic septic shock defined by high endotoxin activity and multiorgan failure, polymyxin B haemoadsorption was associated with a high probability of lower mortality at 28 days and 90 days.
Study context
- Population
- Adults with septic shock requiring vasopressors, multiple organ dysfunction and endotoxin activity 0.60–0.89 units, 19 US hospitals14,890 screened
- Participants
- 157 adults
- Comparison
- Polymyxin B vs Control
- Polymyxin Bn = 106
- Controln = 51reference
- Primary endpoint
- Mortality (ITT cohort)
- Follow-up
- 28 days
Methodological detailsopen-label, Bayesian, phase 3, multicentre, 2:1 randomisation, block randomisation stratified by site, Study personnel masked to treatment allocation
- Open-label
- Bayesian
- Phase 3
- Multicentre
- 2:1 randomisation
- Block randomisation stratified by site
- Study personnel masked to treatment allocation
Primary result
28-day mortality
APACHE-II adjusted OR
0.67
95% CrI 0.39–1.08
Events by treatment group
Polymyxin B vs Control
APACHE-II adjusted OR 0.67 (95% CrI 0.39–1.08)
As reported in the abstract
Secondary outcomes
90-day mortality (key secondary outcome)
- Posterior probability of benefit with polymyxin B vs control
- 99.4%
- APACHE-II adjusted OR
- 0.54 [0.32-0.87] (95% CrI)
- Bayesian analysis
Safety
| Outcome | Polymyxin B | Control | Difference (percentage points) (95% CI) | |
|---|---|---|---|---|
| Serious adverse events (safety cohort) | 30% | 22% | −8 (−22 to 6) | |
| Assessed | 100 | 51 | ||
| −30−20−10010Difference, percentage points (linear scale) |
| Outcome | Polymyxin B | Control |
|---|---|---|
| Treatment-related serious adverse events | 2% | — not stated in the abstract |
— not stated in the abstract
Treatment-related serious adverse events
- One related to polymyxin B, one to catheter placement
Original publication
Polymyxin B haemoadsorption in endotoxic septic shock (Tigris): a multicentre, open-label, Bayesian, randomised, controlled, phase 3 trial. Lancet Respir Med. Published 23 March 2026. doi:10.
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