Menu
Recruiting NCT07679555

Hemodynamic, Laboratory, and Clinical Outcomes of Hemoadsorption Therapy

Observational Hemoadsorption Vasopressor Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hemoadsorption.
Who it may be relevant to
Registry conditions: Hemoadsorption, Vasopressor Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure 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

Primary outcome measures

  • Change in Vasoactive Inotropic Score (VIS) from baseline to 24 hours after completion of hemoadsorption therapy [Time frame: Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy]
Secondary outcome measures (4)
  • Change in Vasopressor Dependency Index (VDI) from baseline to 24 hours after completion of hemoadsorption therapy [Time frame: Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy.]
  • Shock Reversal Time (SRT) [Time frame: 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 [Time frame: 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 [Time frame: Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Hungary · 1 center
  • Pest County Flór Ferenc Hospital, Dept. of Anaesthesiology and Intensive Therapy — Kistarcsa

Identifiers

NCT: NCT07679555 · 169-IK/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗