Recovery After Intensive Care Study: a Single- Center Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- To assess the incidence of post-discharge mortality in patients admitted in ICU.
研究概览
简要总结
Post-ICU long term sequelae- defined as "post intensive care syndrome" (PICS) manifest with a wide spectrum of psychological and cognitive impairments, affecting over two-thirds of ICU survivors and leading to increased rehospitalization, health care costs, impaired quality of life (QoL), inability to return to work and burden for families.
The prevalence of post-traumatic stress symptoms (PTSD), anxiety symptoms, and depression after ICU stay is high and has been demonstrated in up to 50% of post-ICU population.
Therefore, over the last years, an important effort has been made for the development of ICU aftercare and follow-up clinics with the aim to detect and to minimize post-ICU sequelae and improve outcomes. However, the utility of these follow-up programs and their effect on outcome has not been completely demonstrated.
详细描述
This is a single center, prospective observational study, which will be conducted at Policlinico San Martino Hospital, Genova, Italy. Patients admitted to the ICU from more than 72 hours will be consecutively included during a 2 years period.
The primary objective is to assess the incidence of post-discharge mortality in patients admitted in ICU at 12 months.
Secondary objectives include the evaluation at 3, 6 and 12 months of outcome of patients admitted in ICU assessing QoL, anxiety, depression, PTSD, physical ability, cognitive function, sleep disorder and return to previous life; Self- and observer reported cognitive disability at 6 and 12 months after ICU discharge; prognostic factors for poor outcome, and emotional and burden of care impact on the patient's caregivers.
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
- •Age ≥ 18 years;
- •All patients acutely admitted in the ICU from >72 hours, for both medical and surgical pathologies.
排除标准
- •Pregnancy;
- •Refuse of consent to enrolment of patient or of the doctor required to give his approval.
结局指标
主要结局
To assess the incidence of post-discharge mortality in patients admitted in ICU.
时间窗: 12 months
using a neuropsychological evaluation
次要结局
- Cognitive outcome assessed through the MoCA scale, Montreal Cognitive Assessment(12 months)
- Cognitive outcome assessed through HADS scale (Hospital Anxiety and Depression Scale)(12 months)
研究者
Paolo Pelosi
Professor
University of Genova