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Table 4 The main studies describing the effectiveness/limitations of the polymyxin B-immobilized fiber column

From: Extracorporeal techniques for the treatment of critically ill patients with sepsis beyond conventional blood purification therapy: the promises and the pitfalls

 

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

  1. CRRT continuous renal replacement therapy, EAA endotoxin activity assay, PMX polymyxin, AE adverse event, VP vasopressors