Biomarkers of Acute Serious Illness in Children (BASIC): Understanding the Genetic Basis and Biological Pathways Underlying Critical Illness and How They Influence Outcome in Children Requiring Emergency Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 674
- 试验地点
- 4
- 主要终点
- Diagnosis of bacterial infection
研究概览
简要总结
This study is a large multi-centre collaboration between a busy regional paediatric intensive care transport service (Children's Acute Transport Service, CATS), four large paediatric intensive care units (PICUs at Great Ormond Street Hospital, St Mary's Hospital and Royal London Hospital in London, and Addenbrookes Hospital in Cambridge) and the Department of Paediatrics at Imperial College, London. CATS transports over 800 sick children on life support to the three PICUs each year.
We aim to improve our understanding of the genetic basis and biological pathways by which children with acute infection or injury become critically ill and develop failure of vital organs, and how these factors influence outcome. We will establish well-characterised cohorts of sick children with diverse pathologies, in whom blood, urine and other samples will be collected at an early stage of critical illness. Samples will be analysed using genomic, transcriptomic, proteomic and metabolomic approaches. Advanced bioinformatics techniques will be used to identify biomarkers for early diagnosis and robust risk stratification. We will focus on biomarkers to help distinguish between serious bacterial infections, viral infections and other causes of critical illness; diagnose incipient organ failure; and accurately identify, early on, children at high risk of developing a poor outcome.
We will recruit critically ill children at first contact with the CATS team, during emergency transport to PICU. Due to the emergency nature of the research, and minimal risk associated with the study procedure, we will seek deferred, written informed consent from parents/guardians once their child has been stabilised, within 24-48 hours following PICU admission.
By studying these important questions, we aim to better understand how we can diagnose and provide early life-saving treatments to critically ill children. The research team have an established track record of successful completion of several large clinical studies in critical care as well as validation of biomarkers in other diseases.
详细描述
This is a prospective cohort study involving the collection of clinical data and biological samples. No interventions will be performed on patients.
Sample collection Blood and urine samples will be collected at two time points. Stool and throat swabs will also be collected if possible.
Timepoint 1: During stabilisation by the CATS team (first contact with an intensive care team) The CATS team will collect samples during routine sampling, prioritised in the following order: DNA (2 ml); RNA (2 ml); Serum (2 ml); Plasma (2 ml) and Urine (10 ml).
Timepoint 2: Within 24-48 hours of PICU admission The research team in the participating PICU will collect samples during routine sampling, prioritised in the following order: DNA (2 ml); RNA (2 ml); Serum (2 ml); Plasma (2 ml) and Urine (10 ml). In addition, stool and throat swab samples will be collected on the PICU.
In infants less than 10 kg in weight, we will restrict total blood volume collected at each time point to 0.8 ml/kg body weight, in line with MCRN Clinical Trials Guidelines, 25 July 2008.
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
- 0 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill children aged 0-16 years requiring emergency transfer by the Children's Acute Transport Service (CATS) to participating paediatric intensive care units
- •Presence of an indwelling catheter (arterial and/or venous) for blood sampling
- •Presence of a urinary catheter for urine sample collection.
排除标准
- •CATS transfers to other intensive care units or non-intensive care destination units
- •Premature newborns (under 36 weeks corrected gestational age)
- •Children with a known do-not-resuscitate (DNR) order in place.
结局指标
主要结局
Diagnosis of bacterial infection
时间窗: From recruitment until PICU discharge or up to 28 days, whichever occurs earlier
Diagnosis of a bacterial infection by laboratory tests (culture, molecular diagnostics)
Multiorgan failure
时间窗: From recruitment until PICU discharge or up to 28 days, whichever occurs earlier
Failure of two or more organs using the PELOD score
Poor outcome at intensive care unit discharge
时间窗: From recruitment until PICU discharge or up to 28 days, whichever occurs earlier
Mortality or development of severe disability
次要结局
- Long term health related quality of life(12 months after PICU discharge)
- Long term behavioural outcome(12 months after PICU discharge)