Long-term Assessment of Patients Treated in the ICU for Sepsis (LAPTUS)

Hospital Israelita Albert Einstein

Status

Not yet enrolling

Conditions

Sepsis

Treatments

Other: Usual Care

Study type

Observational

Funder types

Other

Identifiers

NCT07502794

LAPTUS registry

Details and patient eligibility

About

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.

Full 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.

Enrollment

760 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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