Immunoglobulin-M-enriched (IgM-enriched) Immunoglobulin Attenuates Systemic Endotoxin Activity in Early Severe Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in endotoxin activity
研究概览
简要总结
The purpose of this study is to evaluate the effect of IgM-enriched immunoglobulins (Pentaglobin) on the endotoxin activity, conventional coagulation parameters, viscoelastic and aggregometric measurements of patients with severe sepsis.
详细描述
Before the change of the standard operating procedure (SOP) with the implementation of the application of IgM-enriched immunoglobulins to patients with severe sepsis and septic shock conventional inflammatory and coagulation parameters, viscoelastic and aggregometric measurements as well as the endotoxin activity was measured in 15 patients. After the change of SOP the same parameters were recorded for additional 15 patients.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •age >18 years
- •proven or suspected severe sepsis or septic shock
- •written consent of the patient or a legal person in charge
排除标准
- •Pregnancy
- •anticoagulation other than heparin
- •Inherited coagulopathy or thrombophilia
结局指标
主要结局
Change in endotoxin activity
时间窗: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
The endotoxin activity of the patients was measured with a point of care assay and noted in on an arbitrary scale from 0 to 1.0
次要结局
- Changes in CT-NATEM(Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours)
- Changes in MCF-NATEM(Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours)
- Changes in CFT-NATEM(Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours)
- Changes in NATEM-Alpha angle(Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours)
- Changes in ADPtest(Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours)
- Changes in ASPItest(Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours)
- Changes in TRAPtest(Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours)
- Platelet count(Baseline, 12, 24, 36, 48, 60, 72 and 84 hours)
- Interleukin-6(Baseline, 12, 24, 36, 48, 60, 72 and 84 hours)
- Leukocyte count(Baseline, 12, 24, 36, 48, 60, 72 and 84 hours)
- Lipopolysaccharide-binding-protein (LBP)(Baseline, 24, 48 and 72 hours)
研究者
Saskia Wand
Dr. Saskia Wand
Goethe University