The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Functions of cell surface markers
研究概览
简要总结
This research project is a study to immunology changes in critically ill patients with severe sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SIRS Criteria > or = 2 meets definition
- •Source of infection > or = 1 meet definition
- •Evidence of organ dysfunction > or = 1 meet definition
排除标准
- •WBC < 5,000 /ul
- •Platelet < 30,000 / ul
- •Pregnancy woman
- •Advance stage cancer patients (terminally ill) who is refuse to be resuscitated
- •Received blood transfusion > 5 units in 24 hrs
- •Allergy to Polymyxin-B
- •High risk and uncontrolled bleeding
- •Organ transplant patients
- •On immunosuppressive agents within 2 weeks before study
- •HIV infection
研究组 & 干预措施
High EAA and use Polymyxin-B Hemoperfusion
EAA level > 0.6 or EAA = 0.6 and use Polymyxin-B Hemoperfusion
干预措施: Polymyxin-B Hemoperfusion (Procedure)
High EAA and not use Polymyxin-B Hemoperfusion
EAA level > 0.6 or EAA = 0.6 and not use Polymyxin-B Hemoperfusion
干预措施: Standard treatment (Procedure)
Low EAA
EAA level < 0.6 and not use Polymyxin-B Hemoperfusion
干预措施: Standard treatment (Procedure)
结局指标
主要结局
Functions of cell surface markers
时间窗: 3 days
CD11b expression on PMN and HLA-DR expression on monocyte
EAA level
时间窗: 3 days
Endotoxin level
Chemotaxis
时间窗: 3 days
Neutrophil function
次要结局
- Sequential Organ Failure Assessment (SOFA Score)(28 days)
- Survival rate(28 days)
- Acute Kidney Injury and Renal Replacement Therapy incidences(28 days)
- ICU length of stay(28 days)
- Mechanical ventilation free day(28 days)
研究者
Nattachai Srisawat ,M.D.
Division of Nephrology, Department of Medicine, Faculty of Medicine
Chulalongkorn University