Long-term Assessment of Patients Treated in the ICU for Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Usual Care.
- Who it may be relevant to
- Registry conditions: Sepsis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Clinical Registry Assessing In-Hospital Management and Post-Discharge Outcomes Among Patients Hospitalized for Sepsis
Overview
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
- Other Usual Care
No study-specific interventions are assigned. All patients receive standard of care for sepsis management according to local protocols and established clinical guidelines.
Primary outcome measures
- All-case mortality [Time frame: 12 months]
Secondary outcome measures (8)
- In-hospital mortality [Time frame: 12 months]
- ICU mortality [Time frame: 12 months]
- Major adverse cardiovascular events [Time frame: 12 months]
- Rehospitalization due to infection [Time frame: 12 months]
- Rehospitalization due to a new sepsis [Time frame: 12 months]
- Health-related quality of life [Time frame: 12 months]
- Healthcare resource utilization [Time frame: 12 months]
- Cognitive impairment [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Hospital São Vicente de Paulo — Passo Fundo
Identifiers
NCT: NCT07502794 · LAPTUS registry