Table 4 Secondary and exploratory outcomes

2.

To compare the change in endotoxin levels between the PMX cartridge-treated group and the control group at 12 hours after completion of a second PMX cartridge, with a treatment target of ≥15% reduction of EAA levels with PMX cartridge treatment

3.

To compare the changes in vasopressor doses for the two groups from day 0 to day 3

4.

To compare the number of days of need for vasopressors in each group from day 0 to day 28 (days alive and off vasopressors)

5.

To compare changes in mean arterial blood pressure for the two groups from day 0 to day 3

6.

Comparison of the changes in renal function from day 0 to day 3:

i.

Fluid balance including urine output

ii.

Serum creatinine

7.

To compare the effects of two uses of the PMX cartridge on progression of, and recovery from, organ dysfunction using the multiple organ dysfunction score from day 0 to day 3

8.

To compare the number of days of need for renal replacement therapy in each group from day 0 to day 28 (days alive and off renal replacement therapy)

9.

To compare the number of days of need for mechanical ventilation in each group from day 0 to day 28 (days alive and off mechanical ventilation)

10.

To compare the mean number of days spent in hospital by subjects in each group for survivors to day 28

11.

To compare survival time from baseline to death within 28 days and compare the risk of death between the two study arms

12.

To compare survival time from baseline to death within 90 days and compare the risk of death between the two study arms