Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection: A Single-arm Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- National Taiwan University Hospital
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Reversal of sepsis-associated circulatory failure
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Ms. Ying Ting Chao
Sheng-Yuan Ruan MD
National Taiwan University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with septic shock defined by the third international consensus definitions for sepsis and septic shock
- •Newly diagnosed pneumonia or urinary tract infection (UTI) defined as the following:
- •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.
- •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).
- •Hyperlactatemia (\>2 mmol/L)
- •Endotoxin activity assay (EAA) ≥ 0.5 units.
Exclusion Criteria
- •Shock persisted \>12 hours before screening
- •Mechanical ventilation \>21 days
- •Uncontrolled hemorrhage
- •Thrombocytopenia (platelet count \< 30,000 cells/mm3)
- •Leukopenia (leukocyte count \< 1500 cells/mm3)
- •Suspected allergy to polymyxin
- •Females with pregnancy
- •Terminal cancer or organ failure with life expectancy less than 30 days
Outcomes
Primary Outcomes
Reversal of sepsis-associated circulatory failure
Time Frame: Day 7
Comparison of the proportion of subjects free from vasopressor on Day 7 between the intervention group and historical control group.
Secondary Outcomes
- Thrombocytopenia (<25,000/μL)(3 days)
- Change of Sequential Organ Failure Assessment (SOFA) score(Day 7)
- 28-day all-cause mortality(28 days)
- Catheter-related complications(3 days)
- Change of endotoxin levels (Endotoxin Activity Assay)(Day 3)
- Vasopressor-free days(7 days)
- Cases with major bleeding needed transfusion with packed red blood cells > 2 units/day(3 days)
- Lactate clearance of survived subjects(Day 3)