Идёт набор NCT07502794

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

— Наблюдательное Sepsis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Usual Care.
Кому может быть актуально: Состояния в реестре: Sepsis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Другое 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.

Первичные конечные точки

All-case mortality [Срок оценки: 12 months]

Вторичные конечные точки (8)

In-hospital mortality [Срок оценки: 12 months]
ICU mortality [Срок оценки: 12 months]
Major adverse cardiovascular events [Срок оценки: 12 months]
Rehospitalization due to infection [Срок оценки: 12 months]
Rehospitalization due to a new sepsis [Срок оценки: 12 months]
Health-related quality of life [Срок оценки: 12 months]
Healthcare resource utilization [Срок оценки: 12 months]
Cognitive impairment [Срок оценки: 12 months]

Критерии участия

Критерии включения

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.