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

Sepsis Clinical Trial

Official title:

Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection: A Single-arm Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02871024
• Other study ID #: 201411023RIPB
• Status: Terminated
• Phase: N/A
• Start date: August 2016
• Est. completion date: March 26, 2019

Study information

• Verified date: March 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 26, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Pneumonia
• Sepsis
• Toxemia
• Urinary Tract Infections

Intervention

Device:
• Toraymyxin
Toraymyxin is an extracorporeal hemoperfusion device designed to reduce blood endotoxin levels in sepsis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversal of sepsis-associated circulatory failure	Comparison of the proportion of subjects free from vasopressor on Day 7 between the intervention group and historical control group.	Day 7
Secondary	Lactate clearance of survived subjects	Comparison of lactate clearance between the intervention group and historical control group. Lactate clearance = (initial lactate level - subsequent lactate level) / (initial lactate level)	Day 3
Secondary	Change of endotoxin levels (Endotoxin Activity Assay)	Change of endotoxin levels after the intervention	Day 3
Secondary	Change of Sequential Organ Failure Assessment (SOFA) score	Comparison of SOFA score between the intervention group and historical control group.	Day 7
Secondary	Vasopressor-free days	Comparison of vasopressor-free days in 7 days between the intervention group and historical control group.	7 days
Secondary	28-day all-cause mortality	Comparison of 28-day all-cause mortality between the intervention group and historical control group.	28 days
Secondary	Catheter-related complications	Comparison of the proportion of the cases with catheter-related complications between the intervention group and historical control group.	3 days
Secondary	Thrombocytopenia (<25,000/µL)	Comparison of the proportion of the cases with thrombocytopenia (<25,000/µL) between the intervention group and historical control group.	3 days
Secondary	Cases with major bleeding needed transfusion with packed red blood cells > 2 units/day	Comparison of the proportion of the cases with major bleeding between the intervention group and historical control group.	3 days