A Prospective Clinical Registry Assessing In-Hospital Management and Post-Discharge Outcomes Among Patients Hospitalized for Sepsis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 760
- Locations
- 1
- Primary Endpoint
- All-case mortality
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Limited prognosis with a life expectancy of less than 3 months due to conditions not related to sepsis.
- •Refusal to participate in the study
Arms & Interventions
Sepsis group
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
All-case mortality
Time Frame: 12 months
Total mortality after inclusion (in-hospital and post-discharge)
Secondary Outcomes
- 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)