Dispositivo Adsorbente Con Polymyxina B Immobilizzata Nello Shock Settico - Studio Clinico Randomizzato e Prospettico, Multicentrico
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Blood pressure and use of vasopressors
研究概览
简要总结
This clinical study designed as a prospective, open labelled, multi-centre, RCT will be carried out to evaluate if direct hemoperfusion with polymyxin B immobilized fiber column (PMX) is superior to conventional medical therapy for sepsis, for patients with sepsis arising from abdominal cavity infection, accompanied by the failure of one or more organs. 120 patients (60 treatment/60 control) will be considered in this study. Those patients fulfilling inclusion criteria and not having exclusion criteria will be randomly allocated to one of two study groups. One group will be treated with PMX (PMX group) and the other will receive a "standard therapy" for sepsis (control group). All patients will receive full intensive care management, including fluid resuscitation, vasopressors, antimicrobial chemotherapy, ventilatory support, and renal replacement therapy, if required. Each patient will be followed up for 28 days after study entry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe sepsis due to intra-abdominal cavity infection after emergency surgery with at least 2 SIRS criteria and 1 organ dysfunction (as defined by SCCM)
排除标准
- •Less than 18 years of age
- •Females with a positive pregnancy test
- •Treated with another investigational drug or device within the 30 days immediately preceding enrolment in this study
- •Undergone organ transplantation during the past one year
- •Documented history of sensitivity to Polymyxin-B, anticoagulant (heparin)
- •Terminally ill, including metastases or hematological malignancy, with a life expectancy less than 30 days (as assessed by the attending physician) or have been classified as "Do Not Resuscitate"
- •Diagnosed with HIV
- •Previous history of end stage chronic organ failure(s)
- •Uncontrolled hemorrhage within the last 24 h
- •Diagnosed with granulocytopenia (leukocyte count of less than 500 cells/mm3) and/or thrombocytopenia (platelet count of less than 30,000 cells/mm3)
- •More than 4 failed organs at entry
- •An APACHE II score of more than 30 at entry to the study
结局指标
主要结局
Blood pressure and use of vasopressors
时间窗: 48-72 hrs
次要结局
- PaO2/ FiO2 ratio(48-72 hrs)
- Change in SOFA score(48-72 hrs)
- ICU survival(28 days)