An interventional study of Toraymyxin in Sepsis, sponsored by National Taiwan University Hospital. Terminated at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-03-28.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 1 is below the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Usual care with two sessions of 2-hour hemoperfusion with Toraymyxin in 24 hours apart
Device: Toraymyxin
Toraymyxin is an extracorporeal hemoperfusion device designed to reduce blood endotoxin levels in sepsis
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.
Time frame: Day 7
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)
Time frame: Day 3
Change of endotoxin levels (Endotoxin Activity Assay)
Change of endotoxin levels after the intervention
Time frame: Day 3
Change of Sequential Organ Failure Assessment (SOFA) score
Comparison of SOFA score between the intervention group and historical control group.
Time frame: Day 7
Vasopressor-free days
Comparison of vasopressor-free days in 7 days between the intervention group and historical control group.
Time frame: 7 days
28-day all-cause mortality
Comparison of 28-day all-cause mortality between the intervention group and historical control group.
Time frame: 28 days
Catheter-related complications
Comparison of the proportion of the cases with catheter-related complications between the intervention group and historical control group.
Time frame: 3 days
Thrombocytopenia (<25,000/μL)
Comparison of the proportion of the cases with thrombocytopenia (\<25,000/μL) between the intervention group and historical control group.
Time frame: 3 days
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.
Time frame: 3 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital