A Prospective Clinical Registry Assessing In-Hospital Management and Post-Discharge Outcomes Among Patients Hospitalized for Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 760
- 试验地点
- 1
- 主要终点
- All-case mortality
研究概览
简要总结
This study is a prospective, observational cohort clinical registry designed to describe clinical and epidemiological characteristics and outcomes of adult patients hospitalized with sepsis. Participants will be followed during hospitalization and after hospital discharge to evaluate short- and long-term outcomes.
详细描述
This is a prospective, observational cohort clinical registry with consecutive enrollment of adult patients hospitalized with sepsis. The study will collect data on clinical and epidemiological characteristics potentially associated with disease severity, hospitalization outcomes, and mortality.
The study will be conducted in up to 30 intensive care units (ICUs) in Brazil, with financial support from the Brazilian Ministry of Health through the PROADI-SUS program. A minimum of 760 participants aged 18 years or older, of any sex, will be enrolled during ICU hospitalization for sepsis.
Outcomes assessed will include in-hospital outcomes and post-discharge outcomes, such as all-cause mortality, unplanned rehospitalizations, health-related quality of life, and cognitive function.
This is an observational study, and no study-related interventions are assigned.
Participants will be enrolled during the in-hospital phase and followed throughout hospitalization and for up to 12 months after hospital discharge. Follow-up assessments will occur at 3, 6, and 12 months post-discharge.
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
- •Clinical diagnosis of sepsis or septic shock during ICU hospitalization, according to the Sepsis-3 definition.
- •Age ≥18 years.
- •Written informed consent obtained from the participant or a legally authorized representative.
排除标准
- •Limited prognosis with a life expectancy of less than 3 months due to conditions not related to sepsis.
- •Refusal to participate in the study
研究组 & 干预措施
Sepsis group
干预措施: Usual Care (Other)
结局指标
主要结局
All-case mortality
时间窗: 12 months
Total mortality after inclusion (in-hospital and post-discharge)
次要结局
- In-hospital mortality(12 months)
- ICU mortality(12 months)
- Major adverse cardiovascular events(12 months)
- Rehospitalization due to infection(12 months)
- Rehospitalization due to a new sepsis(12 months)
- Health-related quality of life(12 months)
- Healthcare resource utilization(12 months)
- Cognitive impairment(12 months)