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

NCT07502794 | Not Yet Recruiting

• 1 other identifier: LAPTUS registry
• Study Type: observational
• Target: 760
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• All-case mortality

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

  12 months

Secondary Outcomes (8)

• 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

Study Arms (1)

Sepsis group

Other: Usual Care

Interventions

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.

Sepsis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (≥18 years) admitted to intensive care units (ICUs) with a clinical diagnosis of sepsis or septic shock, defined according to the Sepsis-3 criteria. Eligible participants must have provided written informed consent, either personally or through a legally authorized representative. Patients with a limited prognosis and an expected life expectancy of less than 3 months due to conditions not related to sepsis, as well as those who decline participation, are excluded from the study.

You may qualify if:

• 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.

You may not qualify if:

• Limited prognosis with a life expectancy of less than 3 months due to conditions not related to sepsis.
• Refusal to participate in the study

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Total plasma

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrique A R Fonseca

  ARO-Einstein - Hospital Israelita Albert Einstein

  STUDY CHAIR

• Luciano C P Azevedo

  ARO-Einstein - Hospital Israelita Albert Einstein

  STUDY CHAIR

Central Study Contacts

Luciano C P Azevedo

CONTACT

55+ 112151-1233; luciano.azevedo@einsten.br

Henrique A Fonseca

CONTACT

55+ 112151-1233; henrique.fonseca@einstein.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: March 31, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share