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

Not Applicable

Terminated

• Conditions: Sepsis
• Interventions: Device: Toraymyxin

• Registration Number: NCT02871024
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-18
• Status Verified: 2019-03
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Toraymyxin	Usual care with two sessions of 2-hour hemoperfusion with Toraymyxin in 24 hours apart

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Change of Sequential Organ Failure Assessment (SOFA) score	Day 7	Comparison of SOFA score 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.
Catheter-related complications	3 days	Comparison of the proportion of the cases with catheter-related complications between the intervention group and historical control group.
Change of endotoxin levels (Endotoxin Activity Assay)	Day 3	Change of endotoxin levels after the intervention
Vasopressor-free days	7 days	Comparison of vasopressor-free days in 7 days 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.
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)

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan