| European pilot study (2005) [37] | EUPHAS (2009) [38] | Japan Registry (2014) [41] | ABDO-MIX (2015) [39] | Japan Registry (2016) [40] | EUPHAS 2 (2016) [42] |
---|---|---|---|---|---|---|
Study design | Multicenter, open-label, pilot, RCT | Multicenter, open-label, prospective RCT | Propensity-matched analysis | Multicenter, prospective RCT | Propensity-matched analysis | Retrospective study |
Study population (n) | 36 patients with intra-abdominal sepsis | 64 patients with intra-abdominal sepsis or septic shock | PMX = 642 intra-abdominal sepsis patients vs 590 propensity score-matched pairs | 232 patients with intra-abdominal septic shock/peritonitis | Septic shock patients with CRRT-requiring AKI | 357 patients with suspected Gram-negative sepsis |
EAA assessment | Measured | Not measured | Not measured | Not measured | Not measured | Some centers |
Prescribed dose | 1 session (2 h) | 2 sessions (2 h) | 1–2 sessions | 1–2 sessions (2 h) | 1–2 sessions | 1–2 sessions (2 h) |
Timing (h) | 24–48 (from diagnosis) | 24 (from abdominal surgery) | 24 (from surgery) | 12 (from surgery) | 24 (from starting CRRT) | 24–48 (from diagnosis) |
Survival/ mortality | Mortality, 29% in the PMX group vs 28% in the control group (p = 0.749) | • PMX group had a significant reduction in 28-day mortality (adjusted HR 0.36; 95% CI 0.16–0.80; p = 0.01) • PMX group had a significant reduction in hospital mortality rate (adjusted HR 0.43; 95% CI 0.21–0.90; p = 0.026) | 28-day mortality was 17.1% in the treatment group and 16.3% in the control group (p = 0.696) | • 28-day mortality 27.7% in the treatment group vs 19.5% in the control group (p = 0.14) • 90-day mortality was 33.6% in the treatment group vs 24% in the control group (p = 0.10) | • The 28-day mortality was 40.2% in the treatment group and 46.8% in the control group (p = 0.003) • 28-day mortality in patients receiving 2 PMX was 35.7% vs 42.6% in the group treated with one session | • 28-day survival 54.5% • ICU survival 55.2% • Hospital survival 50% • Patients with abdominal sepsis treated within 24 h survival 64.5% |
Length of ICU stay | 13.2 ± 9.4 days in the PMX; vs 17.0 ± 9.4 days | No significant difference | – | No significant difference | – | – |
Hemodynamics | Significant improvement in the PMX group | Significant reduction in VP dose in the treatment group | – | No significant difference | No significant difference | – |
Other results | No significant difference in the change of IL-6 levels compared to baseline | – | – | – | – | – |
Safety | Higher AE (mainly change in vitals in the treatment arm) | No adverse events reported | – | 6 severe adverse events (hemorrhagic episodes in the treatment group) Platelet drop | – | Significant platelet drop with no clinical implications |