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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: Usual Care

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.

• Study Type: Observational
• Enrollment (Estimated): 760

Contacts and Locations

• Study Contact: Name: Luciano C P Azevedo; Phone Number: 55+ 112151-1233; Email: luciano.azevedo@einsten.br
• Study Contact Backup: Name: Henrique A Fonseca; Phone Number: 55+ 112151-1233; Email: henrique.fonseca@einstein.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sepsis group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-case mortality	Total mortality after inclusion (in-hospital and post-discharge)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	Incidence of in-hospital mortality	12 months
ICU mortality	Incidence of ICU mortality after inclusion	12 months
Major adverse cardiovascular events	Incidence of major adverse cardiovascular events (myocardial infarction, stroke, or decompensated heart failure) up to 12 months after hospital discharge	12 months
Rehospitalization due to infection	Incidence of need for rehospitalization due to infectious events up to 12 months after hospital discharge.	12 months
Rehospitalization due to a new sepsis	Incidence of new sepsis episodes within 12 months after hospital discharge	12 months
Health-related quality of life	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.	12 months
Healthcare resource utilization	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.	12 months
Cognitive impairment	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	12 months

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Study Chair: Henrique A R Fonseca, ARO-Einstein - Hospital Israelita Albert Einstein; Study Chair: Luciano C P Azevedo, ARO-Einstein - Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: LAPTUS registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No