Sepsis
Conditions
Keywords
Polymyxin B, Pneumonia, Sepsis, Urinary tract infection
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.
Interventions
DEVICEToraymyxin
Toraymyxin is an extracorporeal hemoperfusion device designed to reduce blood endotoxin levels in sepsis
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reversal of sepsis-associated circulatory failure | Day 7 | Comparison of the proportion of subjects free from vasopressor on Day 7 between the intervention group and historical control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of endotoxin levels (Endotoxin Activity Assay) | Day 3 | Change of endotoxin levels after the intervention |
| Change of Sequential Organ Failure Assessment (SOFA) score | Day 7 | Comparison of SOFA score between the intervention group and historical control group. |
| Vasopressor-free days | 7 days | Comparison of vasopressor-free days in 7 days between the intervention group and historical control group. |
| Lactate clearance of survived subjects | Day 3 | Comparison of lactate clearance between the intervention group and historical control group. Lactate clearance = (initial lactate level - subsequent lactate level) / (initial lactate level) |
| Catheter-related complications | 3 days | Comparison of the proportion of the cases with catheter-related complications between the intervention group and historical control group. |
| Thrombocytopenia (<25,000/μL) | 3 days | Comparison of the proportion of the cases with thrombocytopenia (\<25,000/μL) between the intervention group and historical control group. |
| Cases with major bleeding needed transfusion with packed red blood cells > 2 units/day | 3 days | Comparison of the proportion of the cases with major bleeding between the intervention group and historical control group. |
| 28-day all-cause mortality | 28 days | Comparison of 28-day all-cause mortality between the intervention group and historical control group. |
Countries
Taiwan
Outcome results
None listed