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NCT Number: NCT07502794

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Location status: Recruiting

Location contact

Alexandre Tognon, MD

CONTACT

[email protected]

555499911092

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Other

No study-specific interventions are assigned. All patients receive standard of care for sepsis management according to local protocols and established clinical guidelines.

Primary outcomes

  1. All-case mortality

    Time frame: 12 months

    Total mortality after inclusion (in-hospital and post-discharge)

Secondary outcomes

  1. In-hospital mortality

    Time frame: 12 months

    Incidence of in-hospital mortality

  2. ICU mortality

    Time frame: 12 months

    Incidence of ICU mortality after inclusion

  3. Major adverse cardiovascular events

    Time frame: 12 months

    Incidence of major adverse cardiovascular events (myocardial infarction, stroke, or decompensated heart failure) up to 12 months after hospital discharge

  4. Rehospitalization due to infection

    Time frame: 12 months

    Incidence of need for rehospitalization due to infectious events up to 12 months after hospital discharge.

  5. Rehospitalization due to a new sepsis

    Time frame: 12 months

    Incidence of new sepsis episodes within 12 months after hospital discharge

  6. Health-related quality of life

    Time frame: 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.

  7. Healthcare resource utilization

    Time frame: 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.

  8. Cognitive impairment

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Henrique A Fonseca

CONTACT

[email protected]

55+ 112151-1233

Luciano C P Azevedo

CONTACT

[email protected]

55+ 112151-1233

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

A Prospective Clinical Registry Assessing In-Hospital Management and Post-Discharge Outcomes Among Patients Hospitalized for Sepsis

Acronym: LAPTUS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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