Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection
Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection
Toraymyxin is an extracorporeal hemoperfusion cartridge containing Polymyxin B-immobilized
 fiber column designed to reduce blood endotoxin levels in sepsis. Meta-analysis of randomized
 trials showed that polymyxin B hemoperfusion significantly reduced the mortality of severe
 sepsis; however, the evidence was mainly contributed by the studies of abdominal sepsis. The
 data about using polymyxin B hemoperfusion to treat non-abdominal sepsis remain very limited.
 Investigators designed a clinical trial to evaluate the efficacy of polymyxin B hemoperfusion
 on treating non-abdominal severe sepsis. The study hypothesis is that removal of endotoxin by
 polymyxin B hemoperfusion in patients with pneumonia or urinary tract infection (UTI)-related
 severe sepsis will attenuate sepsis associated microcirculation failure and result in early
 reversal of shock and less extent of end-organ damage.
Inclusion Criteria:

 1. Patients with septic shock defined by the third international consensus definitions
 for sepsis and septic shock

 2. Newly diagnosed pneumonia or urinary tract infection (UTI) defined as the following:

 2-1. Pneumonia is defined by a new infiltrate on chest radiograph and the presence of
 one or several of the following signs or symptoms: cough, sputum production, dyspnea,
 core body temperature ≥ 38.0°C, auscultatory findings of abnormal breath sounds and
 rales and leukocyte count > 10000 or < 4000/L.

 2-2. UTI is defined by at least one clinical symptom (core body temperature ≥38.0°C,
 urinary urgency, polyuria, dysuria, suprapubic pain, flank pain, costovertebral angle
 tenderness, nausea and vomiting) and one urinary criterion (pyuria >20 leukocytes/μL).

 3. Hyperlactatemia (>2 mmol/L)

 4. Endotoxin activity assay (EAA) ≥ 0.5 units.

 Exclusion Criteria:

 1. Shock persisted >12 hours before screening

 2. Mechanical ventilation >21 days

 3. Uncontrolled hemorrhage

 4. Thrombocytopenia (platelet count < 30,000 cells/mm3)

 5. Leukopenia (leukocyte count < 1500 cells/mm3)

 6. Suspected allergy to polymyxin

 7. Females with pregnancy

 8. Terminal cancer or organ failure with life expectancy less than 30 days