SepsisLAPTUSNCT07502794
Long-term Assessment of Patients Treated in the ICU for Sepsis
An observational study of Sepsis, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 760 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Jun 2026to Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Limited prognosis with a life expectancy of less than 3 months due to conditions not related to sepsis.
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul
Alexandre Tognon, MD, 555499911092, aptognon@hsvp.com.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Usual Care
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
No study-specific interventions are assigned. All patients receive standard of care for sepsis management according to local protocols and established clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis group | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-case mortality
Total mortality after inclusion (in-hospital and post-discharge)
Measured: 12 months
Secondary outcomes (8)
In-hospital mortality
Incidence of in-hospital mortality
Measured: 12 months
ICU mortality
Incidence of ICU mortality after inclusion
Measured: 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
Measured: 12 months
Rehospitalization due to infection
Incidence of need for rehospitalization due to infectious events up to 12 months after hospital discharge.
Measured: 12 months
Rehospitalization due to a new sepsis
Incidence of new sepsis episodes within 12 months after hospital discharge
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start18 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 760 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrique A R Fonseca, Study chair, ARO-Einstein - Hospital Israelita Albert EinsteinLuciano C P Azevedo, Study chair, ARO-Einstein - Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502794
- Sponsor's protocol ID
- LAPTUS registry
- Acronym
- LAPTUS
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Registry Assessing In-Hospital Management and Post-Discharge Outcomes Among Patients Hospitalized for Sepsis
- ClinicalTrials.gov ID
- NCT07502794
- Acronym / sponsor ID
- LAPTUS / LAPTUS registry
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis group | – | Other: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Limited prognosis with a life expectancy of less than 3 months due to conditions not related to sepsis.
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareNo study-specific interventions are assigned. All patients receive standard of care for sepsis management according to local protocols and established clinical guidelines. | Other | Sepsis group |
Primary outcome
All-case mortality
Time frame: 12 months
Total mortality after inclusion (in-hospital and post-discharge)
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Sepsis
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henrique A R Fonseca study chair
ARO-Einstein - Hospital Israelita Albert Einstein
Luciano C P Azevedo study chair
ARO-Einstein - Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luciano C P Azevedo (55+ 112151-1233, luciano.azevedo@einsten.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-case mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.