Clinical trial NCT02871024: Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection
Official title: Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection: A Single-arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sepsis
Keywords: Polymyxin B
Pneumonia
Sepsis
Urinary tract infection
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reversal of sepsis-associated circulatory failure
timeFrame: Day 7
Secondary outcomes:
measure: Lactate clearance of survived subjects
timeFrame: Day 3
measure: Change of endotoxin levels (Endotoxin Activity Assay)
timeFrame: Day 3
measure: Change of Sequential Organ Failure Assessment (SOFA) score
timeFrame: Day 7
measure: Vasopressor-free days
timeFrame: 7 days
measure: 28-day all-cause mortality
timeFrame: 28 days
measure: Catheter-related complications
timeFrame: 3 days
measure: Thrombocytopenia (<25,000/μL)
timeFrame: 3 days
measure: Cases with major bleeding needed transfusion with packed red blood cells > 2 units/day
timeFrame: 3 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Natioanl Taiwan University Hospital, Taiwan
name: Sheng-Yuan Ruan, MD
role: PRINCIPAL_INVESTIGATOR
References: