PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring, International Registry on the Use of Pentaglobin® in Patients With Severe Bacterial Infections
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 12
- 主要终点
- APACHE II and SAPS II predicted mortality vs. observed hospital mortality and
研究概览
简要总结
International registry on the use of Pentaglobin® in patients with severe bacterial infections; multicentric, international registry, non-interventional trial
详细描述
Aim of the Pentaglobin® registry of adult critically ill patients with severe infections is primarily to assess the effects of IVIgAM on the aforementioned outcome parameters and its side effects under real-life conditions based on a prospective, high-quality data documentation
- Age ≥ 18 years
- Diagnosis of severe bacterial infection
- Pentaglobin® use
- signed informed consent for data collection
Exclusion criteria None
Primary endpoints
- Comparison APACHE II and SAPS II predicted mortality vs. observed hospital mortality and
- Difference in SOFA scores, baseline vs. posttreatment (24 h after last application) assessment
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Diagnosis of severe bacterial infection
- •Pentaglobin® use
- •signed informed consent for data collection -
排除标准
- 未提供
结局指标
主要结局
APACHE II and SAPS II predicted mortality vs. observed hospital mortality and
时间窗: up to 6 months
predicted mortality vs. observed hospital mortality
difference in SOFA scores, baseline vs. posttreatment (24 hours after last application) assessment
时间窗: baseline and 24 hours after last application of Pentaglobin
change in SOFA scores, baseline vs. posttreatment (24 hours after last application)
次要结局
- Duration of ICU stay (days)(up to 6 months)
- In-hospital mortality total and in subgroups according to baseline IgM serum levels and baseline CRP(up to 6 months)
- Change in MOF score from the day before treatment start till 24 hours after last application of Pentaglobin(period between baseline and 24 hours after last application of Pentaglobin)
- Course of laboratory markers (concentration-difference): CRP, procalcitonin, IL-6, IgM, IgA, IgG before treatment start till 24 h after last application as far as available in the centers(period between baseline and 24 hours after last application of Pentaglobin)
- Duration of hospital stay (days)(up to one year)
- Time from onset of severe bacterial infection to start of treatment(up to 14 days)