Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection

National Taiwan University

Status: Terminated

Conditions: Sepsis

Treatments: Device: Toraymyxin

Study type: Interventional

Funder types: Other

Identifiers

NCT02871024

201411023RIPB

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Intervention arm

Experimental group

Description:

Usual care with two sessions of 2-hour hemoperfusion with Toraymyxin in 24 hours apart

Treatment:

Device: Toraymyxin