Sepsis
Conditions
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.
Interventions
OTHERUsual Care
No study-specific interventions are assigned. All patients receive standard of care for sepsis management according to local protocols and established clinical guidelines.
Sponsors
Hospital Israelita Albert Einstein
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-case mortality | 12 months | Total mortality after inclusion (in-hospital and post-discharge) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality | 12 months | Incidence of in-hospital mortality |
| ICU mortality | 12 months | Incidence of ICU mortality after inclusion |
| Major adverse cardiovascular events | 12 months | Incidence of major adverse cardiovascular events (myocardial infarction, stroke, or decompensated heart failure) up to 12 months after hospital discharge |
| Rehospitalization due to infection | 12 months | Incidence of need for rehospitalization due to infectious events up to 12 months after hospital discharge. |
| Rehospitalization due to a new sepsis | 12 months | Incidence of new sepsis episodes within 12 months after hospital discharge |
| Health-related quality of life | 12 months | Score of the health-related quality of life at 3, 6, and 12 months after hospital discharge, assessed using the European Quality of Life 5 Dimensions 5 Level Version - 1 to 5 levels. |
| Healthcare resource utilization | 12 months | Cumulative incidence of healthcare resource utilization (number of outpatient visits, diagnostic tests, hospitalizations, and total length of hospital stay) up to 12 months after hospital discharge. |
| Cognitive impairment | 12 months | Incidence of mild cognitive impairment at 12 months after hospital discharge using the Mini-Mental State Exam (MMSE). Interpretation of the MMSE Scores from 0 to 30: 24-30 - No cognitive impairment 18-23 - Mild cognitive impairment 0-17 - Severe cognitive impairment |
Countries
Brazil
Contacts
CONTACTLuciano C P Azevedo
CONTACTHenrique A Fonseca
STUDY_CHAIRHenrique A R Fonseca
ARO-Einstein - Hospital Israelita Albert Einstein
STUDY_CHAIRLuciano C P Azevedo
ARO-Einstein - Hospital Israelita Albert Einstein
Outcome results
None listed