Predictive Factors of Cytomegalovirus Reactivation or Cytomegalovirus Disease by Immunological Study of Immunocompetent Patients Hospitalized for Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Occurrence of CMV disease
研究概览
简要总结
Cytomegalovirus is a herpesviridae whose prevalence in general population is between 50 to 80%. In immunocompetent individuals, CMV remains latent in a number of cells, without any pathological consequence. Immunosuppression may reactivate the virus causing either a CMV-active infection or a CMV disease with attributable symptoms.
In Intensive Care Unit (ICU), 6 to 30 % of critically ill patients without classical immunosuppression, as those suffering from septic shock, present CMV reactivation. Our aim is to study the risk factors for developing viremia or CMV disease in ICU patients in septic shock without previous immunodepression and determine the relationship between viral reactivation and this acquired immunity alteration.
详细描述
Immunosuppression statuses causing both CMV active infection or disease are mainly consecutive to HIV infection, bone marrow or solid organ transplantation. However, in severely ill patients, as in septic shock, it has been proved that after a hyper-inflammatory phase occurred a negative control of the immunity, resulting in a paralysed or impaired immune system. The length and extent of this immunodeficiency is correlated with the duration of ICU stay, the occurrence of nosocomial infection and mortality.
A better understanding of CMV's natural history reactivation in the critically ill patient would better define the benefits from a specific therapy.
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
- •18 years or older
- •ICU admission for more than 3 days
- •Admission for septic shock
- •Patient with mechanical invasive ventilation
排除标准
- •Immunodepression status before ICU admission (chemotherapy, bone marrow or solid organ transplantation, long time corticosteroid treatment, immunosuppressant therapy, HIV infection)
- •Seronegative patient for CMV
- •Patient under anti-virus treatment
- •Patient under guardianship
结局指标
主要结局
Occurrence of CMV disease
时间窗: From Day 3 of ICU admission to the end of their stay in ICU (in average, from 6 days to 4 weeks)
CMV disease is defined by occurence of viremia and/or an organ failure
次要结局
- Mortality(Day 28)
- Length of ICU stay(About 90 days)
- Duration of mechanical ventilation(About 90 days)
- Occurence of nosocomial infections(About 90 days)
研究者
AdministrateurDRC
Dr Maxime Lugosi
University Hospital, Grenoble