Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Location status: Recruiting
NCT Number: NCT07502794
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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Request Info18 year and older
All sexes
Observational
Passo Fundo, Rio Grande do Sul, Brazil
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No study-specific interventions are assigned. All patients receive standard of care for sepsis management according to local protocols and established clinical guidelines.
Time frame: 12 months
Total mortality after inclusion (in-hospital and post-discharge)
Time frame: 12 months
Incidence of in-hospital mortality
Time frame: 12 months
Incidence of ICU mortality after inclusion
Time frame: 12 months
Incidence of major adverse cardiovascular events (myocardial infarction, stroke, or decompensated heart failure) up to 12 months after hospital discharge
Time frame: 12 months
Incidence of need for rehospitalization due to infectious events up to 12 months after hospital discharge.
Time frame: 12 months
Incidence of new sepsis episodes within 12 months after hospital discharge
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.
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.
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
Contact information is provided by the study sponsor or research team.
Henrique A Fonseca
CONTACT
55+ 112151-1233
Luciano C P Azevedo
CONTACT
55+ 112151-1233
Hospital Israelita Albert Einstein
Other
A Prospective Clinical Registry Assessing In-Hospital Management and Post-Discharge Outcomes Among Patients Hospitalized for Sepsis
Acronym: LAPTUS
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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