Clinical and Biological Characteristics of Critically Ill Patients With COVID-19 Admitted to Pediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patient with secondary infection
研究概览
简要总结
In this prospective longitudinal cohort the investigators reported the clinical, and biological characteristics of all critically ill patients admitted in the pediatric intensive care unit (PICU) of Bicêtre Hospital during the 2019 coronavirus disease (COVID-19) pandemics. Patients were older than 37 weeks of gestational age. No upper limit was set as the unit was transiently converted into a pediatric "adult COVID-19" intensive care unit.
详细描述
All patients will be monitored during their PICU stay.
Clinical characteristics include: age, gender, co-morbidities, organ support therapies (mechanical ventilation, renal replacement therapy, extracorporeal membrane oxygenation, vasopressors), organ complications (pulmonary embolism, acute respiratory distress syndrome, renal failure, heart failure) and function, infective complications (ventilator associated pneumonia, central line associated bloodstream infection, pulmonary access, sepsis, septic shock), microbiologic and viral identification, 7-day and 28-day mortality.
Biological characteristics include:
- Admission workup: qualitative and quantitative Ig, ferritin, creatinine kinase, complement study (C3,C4,CH50),
- Daily workup: blood cells count, arterial blood gas analysis, lactate, electrolytes, albumin, blood urea nitrogen, creatinine, hemostasis (fibrinogen, factor V, II+VII, factor X, prothrombin time, antiXa activity, activated cephalin time, D-dimer), C-reactive protein, procalcitonin.
- Twice weekly workup: circulating cells phenotyping (T cell and subclass including Treg, B cell, Natural Killer cell, myeloid derived suppressor cell, neutrophils), interleukin 6.
- Bone marrow analysis when indicated by attending staff.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suspected or confirmed of severe acute respiratory syndrome Coronavirus 2 infection
- •No opposition from patients or legal representatives after study information
- •Patients admitted to the pediatric intensive care unit of Bicêtre Hospital, Assistance Publique Hôpitaux de Paris - Paris Saclay University
- •Between March 15, 2020 to June 31, 2021
排除标准
- •Patient or legal representative refusal to participate
结局指标
主要结局
Number of patient with secondary infection
时间窗: 2 weeks
Secondary infection will include healthcare associated infections as well as sepsis, and septic shock
次要结局
- Number of patients dying(7-day, 28-day and 60-day)
- Description of clinical phenotypes(through study completion, an average of 4 weeks)
- Description of immunological phenotypes(through study completion, an average of 4 weeks)
研究者
Pierre Tissieres
Professor
Bicetre Hospital