Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Microbiome, metabolic changes and psychological symptoms
研究概览
简要总结
Survivors of critical illness commonly experience long-lasting cognitive, mental health and physical impairments. Clinically significant symptoms of anxiety, depression, and post-traumatic stress disorder (PTSD) may occur in 40%, 34% and 20% of ICU survivors respectively, compared to 6%, 8% and 4% in the general population. These symptoms can persist for more than 8 years.
Evidence shows the existence of a two-way, communication network between gut microbes and the brain referred to as the gut-brain axis. Changes in the microbiome and dysregulation of this communication network in relatively healthy people is associated with cognitive dysfunction and mood disorders such as anxiety and depression. The physiological stress associated with critical illness itself and many ICU interventions including the use of mechanical ventilation and medications such as antibiotics, antacids, vasopressors, and steroids can influence the balance of the gut microbiome and associated metabolites.
This observation study aims to:
- Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery.
- Explore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery.
This knowledge will provide the potential to create interventions that alter the gut environment and microbiome both during and following a critical illness in order to reduce long-term adverse psychological effects. Examples of such potential interventions include dietary modifications with the use of prebiotics or probiotics.
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
- •Unplanned admission to critical care
- •Aged ≥18 years old
- •Requiring mechanical ventilation
- •Commencing ventilation within the previous 24 hours
- •Expected to be ventilated for minimum of ≥72 hours
排除标准
- •Known prior diagnosis of cognitive impairment
- •Known prior mental ill health
- •Known malignancy
- •Admitted after presenting with any of the following conditions:
- •brain injury
- •cardiac arrest
- •immunosuppressed
- •underlying pyogenic infection
- •Not expected to survive to completion of the study
结局指标
主要结局
Microbiome, metabolic changes and psychological symptoms
时间窗: 3 months post-discharge
Explore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery.
Gut microbial and metabolic signatures
时间窗: 3 months post-discharge
Investigate the potential for gut microbial and metabolic signatures at admission and discharge to predict the future development of psychological symptoms following ICU discharge.
Sample repository
时间窗: 3 months post-discharge
Establish a sample repository for future analysis for future studies.
Gut microbiome changes
时间窗: 3 months post-discharge
Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery. (The number and diversity of microbe present)
次要结局
未报告次要终点
