Prognosis of Anxiety in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 1
- 主要终点
- Occurrence of death or organ failure.
研究概览
简要总结
Anxiety is commonly considered as an epiphenomenon of the cognitive and emotional response to a threat. Anxiety is a consequence of the reciprocal interaction between stress and the neuroendocrine, autonomic and immune systems. A systematic and circumstantial assessment of anxiety in critically ill patients has never been done. Our hypothesis is that high levels of anxiety at ICU admission are associated with death or the occurrence of one or more organ failure during the first 7 days, and that anxiety should be considered as a "warning sign" in critically ill patients.
详细描述
Multicentre prospective study. Demographic data, diagnosis, severity scores and vital signs will be assessed at admission.
Within the first 12 hours, and at day 4 and day 7, anxiety will be assessed by the STAI scale, Geriatric Anxiety Inventory (GAI) scale, and a specific questionnaire assessing anxiety in the intensive care (REAX). Visual Analogue Scale (VAS) scoring for anxiety, starvation, thirst, pain and dyspnoea will be collected daily. Anxiety and depression will be evaluated by the Hospital Anxiety and Depression Scale (HADS) on day 7. Patients will be assessed by psychologists or trained doctors, the team in charge of the patient will not be aware of the result of this evaluation.
Clinical and biological data regarding the hemodynamic, neurological, respiratory and renal status will be collected from admission to day 7, as well as parameters required for computing the Sequential Organ Failure Assessment (SOFA) score.
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
- •All adult patients admitted to the ICU
- •Patient without delirium at admission (assessed using the CAM-ICU score)
排除标准
- •Severe hearing impairment or poor understanding of French language
- •History of serious psychiatric illness
- •Comatose or sedated patient at admission
- •Diagnosis of voluntary self-poisoning, or polytrauma at admission
结局指标
主要结局
Occurrence of death or organ failure.
时间窗: 7 days
次要结局
- Severity of an ongoing organ failure (maximum SOFA score)(7 days)
- 1-Occurrence of shock, delirium, or stress-related complications (upper gastrointestinal bleeding, acute coronary syndrome)(7 days)
- Assessment of anxiety according to State Trait Anxiety Inventory score (STAI)(7 days)
- Assessment of anxiety according to REAX score(7 days)
- Assessment of Geriatric Anxiety Inventory score (GAI)(7 days)
- Assessment of anxiety according to the Visual Analog Scale (VAS)(7 days)
研究者
Tarek Sharshar
Tarek SHARSHAR, MD, PHD
Assistance Publique - Hôpitaux de Paris