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临床试验/NCT07679555
NCT07679555招募中不适用

Hemodynamic, Laboratory, and Clinical Outcomes of Hemoadsorption theraPy: an obsErvational Study at Flór Ferenc Hospital Using Longitudinal Data (HOPE-FUL)

Pest County Flór Ferenc Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Change in Vasoactive Inotropic Score (VIS) from baseline to 24 hours after completion of hemoadsorption therapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years;
  • CytoSorb or Efferon LPS hemoadsorption treatment,
  • with available relevant pre- and post-treatment clinical and laboratory data

排除标准

  • age under 18 years
  • missing key demographic or outcome data;
  • unknown treatment type or timing;
  • data unavailable for legal or ethical reasons.

研究组 & 干预措施

Patients receiving hemoadsorption treatment

Critically ill patients who received hemoadsorption therapy using CytoSorb or Efferon LPS between January 1 2020 and May 31 2026

干预措施: Hemoadsorption (Procedure)

结局指标

主要结局

Change in Vasoactive Inotropic Score (VIS) from baseline to 24 hours after completion of hemoadsorption therapy

时间窗: Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy

The primary endpoint is the change in vasopressor and inotropic support requirements, quantified using the Vasoactive Inotropic Score (VIS), from immediately before initiation of hemoadsorption therapy (baseline) to 24 hours after completion of treatment. VIS is calculated as: VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10 × vasopressin (U/kg/min)

次要结局

  • Change in Vasopressor Dependency Index (VDI) from baseline to 24 hours after completion of hemoadsorption therapy(Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy.)
  • Change in laboratory biomarkers from baseline to immediately after and 24 hours after completion of hemoadsorption therapy(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(Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy.)
  • Shock Reversal Time (SRT)(From initiation of hemoadsorption therapy until achievement of shock reversal, assessed during the first 24 hours after completion of hemoadsorption therapy.)

研究者

发起方
Pest County Flór Ferenc Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zoltan Ruszkai, MD, PhD

Head of Department of Anesthesiology and Intensive Therapy

Pest County Flór Ferenc Hospital

研究点 (1)

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