Back to resultsEfficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection
Primary Purpose
Sepsis
Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Toraymyxin
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Polymyxin B, Pneumonia, Sepsis, Urinary tract infection
Eligibility Criteria
Inclusion Criteria:
- Patients with septic shock defined by the third international consensus definitions for sepsis and septic shock
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).
- Hyperlactatemia (>2 mmol/L)
- Endotoxin activity assay (EAA) ≥ 0.5 units.
Exclusion Criteria:
- Shock persisted >12 hours before screening
- Mechanical ventilation >21 days
- Uncontrolled hemorrhage
- Thrombocytopenia (platelet count < 30,000 cells/mm3)
- Leukopenia (leukocyte count < 1500 cells/mm3)
- Suspected allergy to polymyxin
- Females with pregnancy
- Terminal cancer or organ failure with life expectancy less than 30 days
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Usual care with two sessions of 2-hour hemoperfusion with Toraymyxin in 24 hours apart
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Change of endotoxin levels (Endotoxin Activity Assay)
Change of endotoxin levels after the intervention
Change of Sequential Organ Failure Assessment (SOFA) score
Comparison of SOFA score between the intervention group and historical control group.
Vasopressor-free days
Comparison of vasopressor-free days in 7 days between the intervention group and historical control group.
28-day all-cause mortality
Comparison of 28-day all-cause mortality between the intervention group and historical control group.
Catheter-related complications
Comparison of the proportion of the cases with catheter-related complications between the intervention group and historical control group.
Thrombocytopenia (<25,000/μL)
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
Comparison of the proportion of the cases with major bleeding between the intervention group and historical control group.
Full Information
NCT ID
NCT02871024
First Posted
August 4, 2016
Last Updated
March 26, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02871024
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficult recruitment
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 26, 2019 (Actual)
Study Completion Date
March 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Polymyxin B, Pneumonia, Sepsis, Urinary tract infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Usual care with two sessions of 2-hour hemoperfusion with Toraymyxin in 24 hours apart
Intervention Type
Device
Intervention Name(s)
Toraymyxin
Intervention Description
Toraymyxin is an extracorporeal hemoperfusion device designed to reduce blood endotoxin levels in sepsis
Primary Outcome Measure Information:
Title
Reversal of sepsis-associated circulatory failure
Description
Comparison of the proportion of subjects free from vasopressor on Day 7 between the intervention group and historical control group.
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Lactate clearance of survived subjects
Description
Comparison of lactate clearance between the intervention group and historical control group. Lactate clearance = (initial lactate level - subsequent lactate level) / (initial lactate level)
Time Frame
Day 3
Title
Change of endotoxin levels (Endotoxin Activity Assay)
Description
Change of endotoxin levels after the intervention
Time Frame
Day 3
Title
Change of Sequential Organ Failure Assessment (SOFA) score
Description
Comparison of SOFA score between the intervention group and historical control group.
Time Frame
Day 7
Title
Vasopressor-free days
Description
Comparison of vasopressor-free days in 7 days between the intervention group and historical control group.
Time Frame
7 days
Title
28-day all-cause mortality
Description
Comparison of 28-day all-cause mortality between the intervention group and historical control group.
Time Frame
28 days
Title
Catheter-related complications
Description
Comparison of the proportion of the cases with catheter-related complications between the intervention group and historical control group.
Time Frame
3 days
Title
Thrombocytopenia (<25,000/μL)
Description
Comparison of the proportion of the cases with thrombocytopenia (<25,000/μL) between the intervention group and historical control group.
Time Frame
3 days
Title
Cases with major bleeding needed transfusion with packed red blood cells > 2 units/day
Description
Comparison of the proportion of the cases with major bleeding between the intervention group and historical control group.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with septic shock defined by the third international consensus definitions for sepsis and septic shock
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).
Hyperlactatemia (>2 mmol/L)
Endotoxin activity assay (EAA) ≥ 0.5 units.
Exclusion Criteria:
Shock persisted >12 hours before screening
Mechanical ventilation >21 days
Uncontrolled hemorrhage
Thrombocytopenia (platelet count < 30,000 cells/mm3)
Leukopenia (leukocyte count < 1500 cells/mm3)
Suspected allergy to polymyxin
Females with pregnancy
Terminal cancer or organ failure with life expectancy less than 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Yuan Ruan, MD
Organizational Affiliation
Natioanl Taiwan University Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection
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