A Study in Sepsis Patients With Renal Failure

This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Alkaline Phosphatase, inflammation, infection, renal failure Read More

Inclusion Criteria:

• Patients between the age of 18 and 80 years.
• Proven or suspected infection.

• Two out of four SIRS criteria of systemic inflammation, existing for less than 24 hours after admission in the intensive care unit, as follows:

  • Core temperature higher then 38 degree Celsius or lower then 36 degree Celsius.
  • Heart rate above 90 beats/min (unless the patient has a medical condition known to increase heart rate or is receiving treatment that would prevent tachycardia).
  • Respiratory rate above 20 breaths/min, a PaCO2 lower then 32mmHg or the use of mechanical ventilation for an acute respiratory process.
  • White-cell count above 12,000/mm3 or below 4,000/mm3 or a differential count showing >10 percent immature neutrophils.

• Acute renal failure, defined as

  • Rise in serum creatinine level to ≥150μmol/L within the previous 48 hours, in the absence of primary underlying renal disease OR
  • Minimally a stage 1 Kidney Injury according to AKIN creatinine criteria: Increase in serum creatinine ≥26.2µmol/L (0.3mg/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) OR
  • Minimally a stage 1 Kidney Injury according to AKIN Urine Output criteria: Urine Output of ≤ 0.5mg/kg/h for ≥6h and following adequate fluid resuscitation when applicable, in the absence of underlying primary renal disease and where baseline creatinine is less than 150µmol/L)
• Written informed consent obtained prior to any study intervention.

Exclusion Criteria:

• Pregnant women or nursing mothers and fecund females who are not on effective contraception (chemical: pill; or mechanical: IUD)
• Patients already on dialysis (RTT) at entry
• Known HIV (sero-positive) patients
• Patients receiving immunosuppressant therapy or on chronic high doses of steroids equivalent to prednisone 1mg/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
• Patients not expected to survive for 28 days due to other medical conditions such as end-stage neoplasm or other diseases
• Participation in another investigational study within 90 days prior to start of the study which might interfere with this study
• Any previous administration of active study medication.
• Known allergy for dairy (bovine) products including cow milk.
• Sepsis without renal failure as defined in the Entry Criteria.
• History of chronic renal failure or history of persistent creatinine level equal or greater than 150umol/L prior to entry for reasons other than the current sepsis condition".