Hemodynamic, Laboratory, and Clinical Outcomes of Hemoadsorption Therapy
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: Hemoadsorption.
- Кому может быть актуально
- Состояния в реестре: Hemoadsorption, Vasopressor Therapy. 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
- Венгрия
- 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
Hemodynamic, Laboratory, and Clinical Outcomes of Hemoadsorption theraPy: an obsErvational Study at Flór Ferenc Hospital Using Longitudinal Data (HOPE-FUL)
Обзор
This single-center retrospective observational cohort study aims to evaluate the clinical, hemodynamic, and laboratory effects of adjunctive hemoadsorption therapy in critically ill adult patients treated in the Intensive Care Unit of Flór Ferenc Hospital, Hungary, between January 1, 2020, and May 31, 2026. Patients who received CytoSorb® or Efferon LPS® hemoadsorption therapy will be included. The study will assess changes in vasopressor requirements, hemodynamic parameters, inflammatory biomarkers, liver function tests, tissue perfusion markers, and oxygenation following hemoadsorption treatment. Clinical outcomes, including intensive care unit length of stay, all-cause mortality occurring during the patient's stay in the intensive care unit (ICU mortality), and 28-day and 90-day mortality, will also be evaluated. Data will be collected retrospectively from anonymized medical records, and no study-related interventions will be performed.
Подробное описание
Sepsis, septic shock, and other severe systemic inflammatory conditions remain among the leading causes of morbidity and mortality in critically ill patients. Dysregulated inflammatory host response is characterized by the excessive release of cytokines, endotoxins, and other inflammatory mediators, which contribute to endothelial injury, microcirculatory dysfunction, vasoplegia, tissue hypoperfusion, organ dysfunction, and multiple organ failure.
Hemoadsorption is an extracorporeal blood purification technique designed to remove circulating inflammatory mediators, toxins, drugs and other harmful molecules. Several hemoadsorption devices, including CytoSorb® and Efferon LPS®, have been increasingly used as adjunctive therapies in patients with septic shock and other hyperinflammatory conditions. Although their use has expanded substantially in daily clinical practice, evidence regarding their effectiveness remains heterogeneous or even controversial, that is why additional clinical data are needed to better define their role and impact on patient outcomes.
This single-center retrospective observational cohort study will evaluate the clinical, hemodynamic, and laboratory effects of adjunctive hemoadsorption therapy in adult patients treated in the Department of Anesthesiology and Intensive Therapy at Flór Ferenc Hospital, Kistarcsa, Hungary, between January 1, 2020, and May 31, 2026. Eligible patients are those who received CytoSorb® or Efferon LPS® hemoadsorption therapy as part of routine clinical care.
The primary objective is to assess the effect of hemoadsorption therapy on vasopressor requirements, measured by changes in the Vasoactive Inotropic Score (VIS). Secondary outcome measures include evaluation of changes in the Vasopressor Dependency Index (VDI), shock reversal time, inflammatory biomarkers (procalcitonin and C-reactive protein), liver function parameters (transaminases and bilirubin), tissue perfusion markers (arterial lactate concentration), and oxygenation indicated by the arterial oxygen partial pressure to inspired oxygen fraction ratio (PaO₂/FiO₂) ratio. Additional outcomes include changes in organ dysfunction severity scores, intensive care unit length of stay, all-cause mortality occurring during the patient's stay in the intensive care unit (ICU mortality), and 28-day and 90-day mortality.
Data will be collected retrospectively from anonymized electronic medical records, intensive care documentation systems, laboratory information systems, extracorporeal treatment records, and national electronic health records used to verify survival outcomes. No study-specific interventions, diagnostic procedures, or alterations in patient management will be performed. The study is designed to generate real-world evidence regarding the effectiveness of hemoadsorption therapy and to improve understanding of its impact on hemodynamic stabilization, inflammatory response, organ function, and survival in critically ill patients.
Вмешательства
- Процедура Hemoadsorption
Patients included in this retrospective observational study received adjunctive hemoadsorption therapy as part of routine clinical care at the discretion of the treating intensive care physicians. Hemoadsorption was performed using either the CytoSorb® or Efferon LPS® hemoadsorption cartridge, according to the clinical indication and device availability. Hemoadsorption was integrated into a continuous renal replacement therapy (CRRT) circuit. Treatment duration, number of hemoadsorption session
Первичные конечные точки
- Change in Vasoactive Inotropic Score (VIS) from baseline to 24 hours after completion of hemoadsorption therapy [Срок оценки: Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy]
Вторичные конечные точки (4)
- Change in Vasopressor Dependency Index (VDI) from baseline to 24 hours after completion of hemoadsorption therapy [Срок оценки: Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy.]
- Shock Reversal Time (SRT) [Срок оценки: From initiation of hemoadsorption therapy until achievement of shock reversal, assessed during the first 24 hours after completion of hemoadsorption therapy.]
- Change in laboratory biomarkers from baseline to immediately after and 24 hours after completion of hemoadsorption therapy [Срок оценки: Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy.]
- Change in oxygenation (PaO₂/FiO₂ ratio) from baseline to immediately after and 24 hours after completion of hemoadsorption therapy [Срок оценки: Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy.]
Критерии участия
Критерии включения
- >18 years;
- CytoSorb or Efferon LPS hemoadsorption treatment,
- with available relevant pre- and post-treatment clinical and laboratory data
Критерии исключения
- age under 18 years
- missing key demographic or outcome data;
- unknown treatment type or timing;
- data unavailable for legal or ethical reasons.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Венгрия · 1 центр
- Pest County Flór Ferenc Hospital, Dept. of Anaesthesiology and Intensive Therapy — Kistarcsa
Идентификаторы
NCT: NCT07679555 · 169-IK/2026