MIRSEP - MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Difference in the miRNA-expression pattern in critically ill patients with/without sepsis-induced immunosuppression
研究概览
简要总结
Sepsis-induced immunosuppression (SIS) is a common complication in patients with septic shock. Reduced expression of Human leukocyte antigen isotype DR (HLA-DR) on circulating monocytes is a marker for SIS and correlates with risk of secondary infections and mortality. The miRSep study aims to improve the understanding of early microRNA (miRNA) mediated changes in HLA-DR on monocytes in patients with septic shock.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic shock:
- •New onset (<24h) of septic shock diagnosis according to Sepsis-3 definition
- •(suspected) infection
- •Vasopressors required to maintain mean arterial pressure ≥65mm Hg (despite adequate fluid resuscitation)
- •Serum lactate level > 2mmol/L
- •Minimum age of 18 years
- •Expected length of stay >48h
- •Written consent from an independent physician
- •Critically ill:
- •Patients on mechanical ventilation (MV) in the ICU without an admission diagnosis of sepsis/septic shock according to Sepsis-3 definition
- •Minimum age of 18 years
- •Expected length of stay >48h
- •Written consent from an independent physician
排除标准
- •Age < 18 years
- •Patients known not to speak German or French
- •Patients with known.
- •Pre-existing congenital or acquired severe immune deficiency (e.g. severe combined immunodeficiency, HIV infection, AIDS) or
- •current immunosuppressive therapy (immunosuppressive biologicals or active lymphocyte therapy e.g. endoxan, rituximab or corticosteroid use at a dose > 10 mg/day equivalent of prednisone. However, acute corticosteroid treatment of a relative adrenal insufficiency using a maximum hydrocortisone dose of 200 mg/day is accepted.
研究组 & 干预措施
Critically ill patients
Critically ill patients in ICU without sepsis diagnosis
Septic shock
Patients in ICU with diagnosed septic shock
结局指标
主要结局
Difference in the miRNA-expression pattern in critically ill patients with/without sepsis-induced immunosuppression
时间窗: 3 Days following ICU admission
Determine the early expression of specific miRNA candidates in monocytes of patients with sepsis induced immunosuppression compared to critically ill patients without sepsis induced immunosuppression using quantification by RT-qPCR
次要结局
- Correlation between miRNA expression and sepsis outcome (30-day mortality)(30 days following ICU admission)