Table 1 Patient entry selection

   • Age: 18 to 80 years, inclusive

   • Diagnosis: proven or suspected infection

   • Two out of four SIRS criteria of systemic inflammation [36]

- Core temperature > 38° or < 36° Celsius

- Heart rate > 90 beats/minute (unless the patient has a medical condition known to increase heart rate or is receiving treatment that would prevent tachycardia)

- Respiratory rate > 20 breaths/minute, PaCO₂ < 32 mmHg or the use of mechanical ventilation for an acute respiratory process

- White-cell count > 12,000/mm³ or < 4,000/mm³ or a differential count showing > 10% immature neutrophils.

   • Acute Kidney Injury, defined as:

   • Rise in serum creatinine level to > 150 μmol/L (1.70 mg/dL) within the previous 48 hours, in the absence of primary underlying renal disease, OR

   • Minimally at Stage 1 Kidney Injury according to AKIN creatinine criteria: Increase in serum creatinine > 26.2 μmol/L (0.30 mg/dL) or increase to > 150% (> 1.5-fold) from baseline in the previous 48 hours in the absence of primary underlying renal disease and where baseline creatinine is less than 150 μmol/L (1.70 mg/dL)), OR

   • Minimally at Stage 1 Kidney Injury (AKIN) Urine Output criteria: Urine Output < 0.5 mL/kg/h for > 6 h and following adequate fluid resuscitation when applicable, in the absence of underlying primary renal disease and where baseline creatinine is less than 150 μmol/L (1.70 mg/dL).

• Written informed consent obtained prior to any study intervention.

In addition to the above, acute onset of end-organ dysfunction (other than renal failure) in the preceding 12 hours unrelated to the primary septic focus and not explained by any underlying chronic disease [15]may be present (not compulsory) for patient qualification for enrollment)

Exclusion criteria

   • Pregnant women or nursing mothers and fecund females not on effective contraception

   • Known HIV (sero-positive) patients

   • Patients already on RRT at entry

   • Patients receiving immunosuppressant therapy or on chronic high doses of steroids equivalent to prednisone 1 mg/kg/day

   • Patients expected to have rapidly fatal disease within 24 hours

   • Known confirmed gram-positive sepsis

   • Known confirmed fungal sepsis

   • Acute pancreatitis with no established source of infection

   • Any previous administration of exogenous AP

   • Participation in another investigational study within 90 days

   • Patients not expected to survive for 28 days due to other medical conditions such as end-stage neoplasm

   • Known allergy to dairy products including cow milk

   • Sepsis without renal failure as defined in Entry Criteria

   • History of chronic renal failure or history of persistent creatinine level equal or greater than 150 μmol/L (1.70 mg/dL) prior to entry for reasons other than the current sepsis condition