Table 5 The main studies describing the effectiveness/limitations of the Cytosorb cartridge

Study design

Multicenter, open label, RCT

Prospective interventional single center

Multicenter, open label, RCT

Case series

Study population (n)

43 septic patients with ALI

25 septic shock patients

97 septic patients with ALI or ARDS

16 septic shock patients

IL-6 assessment (pg/ml)

–

> 1000

Average of 565

–

Prescribed dose

ST vs ST + HP (6 h/day for 7 days)

One session in the pre-filter mode. Further treatments at the discretion of the study physicians

HP vs no HP (6 h/day for up to 7 days)

RRT as clinically indicated in both groups

HP in the pre-filter mode (1–5 treatments)

Timing

–

Within 24 h

–

< 24 to > 48 h (outcomes better in the early group)

Survival

28-day mortality 28% in the treatment group vs 24% in the controls (p = 0.84)

60-day mortality (39% in the treatment group vs 32% the controls (p = 0.75)

–

28-day mortality 36.2% in the treatment group vs 18.0% in the controls (p = 0.073)

60-day mortality of 44.7% in the treatment group vs 26.0% in the controls (p = 0.039)

The actual 28-day, ICU, and hospital mortality was 61.54%, 73.08%, and 80.77%, respectively, compared with 89.9% as predicted by APACHE II score

Hemodynamics

–

Significant reduction in VP requirements compared to baseline

–

Significant reduction in VP requirements compared with baseline

Other results

Significant reduction in IL-6

Significant reduction in IL-6

IL-6 reduction in the HP group compared with no HP

–

Safety

Modest reduction in platelet count (< 10%) and albumin (< 5%)

No AE

1 drop in platelets in the treatment group

No AE