Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection: A Single-arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Reversal of sepsis-associated circulatory failure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
- •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.
排除标准
- •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
结局指标
主要结局
Reversal of sepsis-associated circulatory failure
时间窗: Day 7
Comparison of the proportion of subjects free from vasopressor on Day 7 between the intervention group and historical control group.
次要结局
- Thrombocytopenia (<25,000/μL)(3 days)
- Change of Sequential Organ Failure Assessment (SOFA) score(Day 7)
- 28-day all-cause mortality(28 days)
- Catheter-related complications(3 days)
- Change of endotoxin levels (Endotoxin Activity Assay)(Day 3)
- Vasopressor-free days(7 days)
- Cases with major bleeding needed transfusion with packed red blood cells > 2 units/day(3 days)
- Lactate clearance of survived subjects(Day 3)
研究者
Ms. Ying Ting Chao
Sheng-Yuan Ruan MD
National Taiwan University Hospital