Diagnostic Biomarkers for Adult Hemophagocytic Lymphohistiocytosis in Critically Ill Patients (HEMICU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of HLH in intensive care units based on HLH-2004 criteria
研究概览
简要总结
Hemophagocytic lymphohistiocytosis in adults (HLH) is at 68% mortality whereas 78% of all cases remain undiagnosed though therapies are available which clearly reduce mortality. The investigators aim to systematically investigate this life-threatening hyperinflammatory syndrome in intensive care units (ICU) in order to detect biomarkers that are highly sensitive and highly specific for HLH in ICU compared to patients with sepsis.
详细描述
The investigators will draw blood samples of 100 patients at the time of diagnosis (each 50 with suspected or diagnosed HLH/sepsis) to determine a cytokine panel (c reactive protein (CRP), procalcitonin (PCT), interleukin (IL) 1β, IL-6, IL-8, IL-10, IL-18, IL-33, tumor necrosis factor (TNF) α, interferon (IFN) ɣ, soluble IL-2 receptor (sIL-2R), the EBV and CMV viral loads, human immunodeficiency virus (HIV) antibodies and -antigen, perforin, fibrinogen, triglycerides, bilirubin, lactate dehydrogenase, liver transaminases, sodium, serum albumin, electrophoresis, glycosylated ferritin, the microRNAs miR-205-5p, miR-194-5p and miR-30c-5p, perforin, CD107a and high immune status (differential blood count, T cells, B cells, NK cells, T helper cells, cytotoxic T cells, CD4 / CD8 ratio, HLA-DR of CD8 +, CD11a of CD8, CD57 of CD8, CD28 of CD8 +, HLA-DR of monocytes, CD56bright and CD69 of NK cells). The results of this study serve the development of new clinical concepts in order to safely diagnose HLH at an early stage, to distinguish from sepsis and to reduce the fatal consequences.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female critically ill patients
- •At least 18 years old
- •Suspected or diagnosed HLH
排除标准
- •Female patients: Pregnancy
- •Female patients: Breastfeeding
结局指标
主要结局
Incidence of HLH in intensive care units based on HLH-2004 criteria
时间窗: Up to 180 days
HLH patients are followed up until the end of hospital stay or death.
次要结局
- Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) viral loads(Up to 180 days)
- Perforin and CD107a(Up to 180 days)
- Human immunodeficiency virus antibodies and -antigen(Up to 180 days)
- Liver transaminase (ASAT)(Up to 180 days)
- Sodium(Up to 180 days)
- Detailed immune status(Up to 180 days)
- Mortality(Up to 180 days)
- Bilirubin(Up to 180 days)
- Serum albumin(Up to 180 days)
- Cytokine panel(Up to 180 days)
- Fibrinogen(Up to 180 days)
- Liver transaminases (ALAT)(Up to 180 days)
- Glycosylated ferritin(Up to 180 days)
- Intensive care unit stay(Participants will be followed up for the duration of hospital length of stay, an expected average of 4 weeks)
- Hospital stay(Participants will be followed up for the duration of hospital length of stay, an expected average of 8 weeks)
- Lactate dehydrogenase(Up to 180 days)
- microRNAs miR-205-5p, miR-194-5p and miR-30c-5p(Up to 180 days)
- Triglycerides(Up to 180 days)
- Serum protein electrophoresis(Up to 180 days)
研究者
Claudia Spies
Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin
Charite University, Berlin, Germany