Immune Failure in Critical Therapy(INFECT) Study: Phenotyping Immune Cell Dysfunction to Predict Outcomes in Critically Ill Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 4
- 主要终点
- The development of immune dysfunction (see below) and its association with ICU-acquired infection within the 16 day study period.
研究概览
简要总结
Patients admitted to intensive care units (ICU) are at high risk of developing secondary infections, and this is in part due to dysfunction or failure of their 'germ killing' functions (the immune system). Our group has recently identified three signatures of immune system failure which can be readily detected on a blood sample, and importantly, appear to predict the chances of developing secondary infection. Such a test would have major benefits for the management of patients in intensive care if it can be translated into a test usable in everyday clinical practice. This study aims to validate our original findings in a cohort of patients from multiple ICUs, using a test which will be suitable for everyday clinical practice, and thus take the next step towards developing a market-ready test.
Study hypothesis:
Measurement of neutrophil CD88, monocyte HLA-DR and percentage Tregs will accurately predict the risk of nosocomial infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >16 (>18 in England)
- •Requiring level 3 care (i.e. requiring invasive support of respiratory system alone, or two or more other organ systems (haemofiltration, inotropes/vasopressors)
- •Predicted to remain in ICU for at least 48 hours,
排除标准
- •Not expected to survive for a further 24 hours
- •Known or suspected ICU-acquired infection at time of screening (non-ICU acquired nosocomial infection - i.e. non-ICU healthcare associated infection is NOT and exclusion)
- •Known inborn errors of immune function
- •Immunosuppression (corticosteroids up to 400mg hydrocortisone equivalent daily dose permitted)
- •HIV infection
- •Pregnancy
- •Previously enrolled in the study
结局指标
主要结局
The development of immune dysfunction (see below) and its association with ICU-acquired infection within the 16 day study period.
时间窗: Within the first 16 days
次要结局
- Death from sepsis(Within first 16 days)
- Organ dysfunction as determined by SOFA score(Within first 14 days)
- Length of ICU stay(Up to 3 months (for current hospital admission only))
- ICU Outcome (lived/died)(Within first 16 days)
- Duration of organ support in ICU(Within first 14 days)