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

ConditionSepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Israelita Albert Einstein

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Usual Care

    Other intervention

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

Treatment groups

760 Participants
are divided into 1 treatment group
Group A: Sepsis group1 intervention

Trial outcomes

Primary outcomes

1

All-case mortality

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

Time frame
12 months

Secondary outcomes

1

In-hospital mortality

Incidence of in-hospital mortality

Time frame
12 months
2

ICU mortality

Incidence of ICU mortality after inclusion

Time frame
12 months
3

Major adverse cardiovascular events

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

Time frame
12 months
4

Rehospitalization due to infection

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Israelita Albert Einstein

Lead sponsor

Source ClinicalTrials.gov
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