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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving hemoadsorption treatment | Critically ill patients who received hemoadsorption therapy using CytoSorb or Efferon LPS between January 1 2020 and May 31 2026 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoadsorption | Procedure | 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 sessions, timing of therapy initiation, and concomitant intensive care interventions were determined by the treating physicians and were not influenced by the study protocol. No study-specific interventions, additional diagnostic procedures, or protocol-mandated treatments were performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vasoactive Inotropic Score (VIS) from baseline 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) | Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vasopressor Dependency Index (VDI) from baseline to 24 hours after completion of hemoadsorption therapy | The secondary endpoint is the change in vasopressor dependency, quantified using the Vasopressor Dependency Index (VDI), from immediately before initiation of hemoadsorption therapy (baseline) to 24 hours after completion of treatment. The VDI is a hemodynamic severity index that quantifies the relationship between vasopressor requirements and mean arterial pressure (MAP). Higher VDI values indicate greater hemodynamic instability and are associated with increased disease severity, a higher risk of mortality, and, in patients with septic shock, a greater likelihood of severe vasoplegia. The VDI is calculated as: VDI = (NEE / MAP) × 100 where: NEE (Norepinephrine Equivalent dose) = norepinephrine (µg/kg/min) + epinephrine (µg/kg/min) + 0.01 × dopamine (µg/kg/min) + 0.06 × phenylephrine (µg/kg/min) + 2.5 × vasopressin (U/min) MAP = mean arterial pressure (mmHg) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sequential Organ Failure Assessment (SOFA) score from baseline to Day 2 (24 hours after completion of hemoadsorption therapy) | Changes in organ dysfunction will be assessed using the Sequential Organ Failure Assessment (SOFA) score. The SOFA score will be recorded immediately before initiation of hemoadsorption therapy (baseline) and 24 hours after completion of therapy. Both absolute and relative changes in the SOFA score will be calculated: (1) Absolute change = post-treatment SOFA score - baseline SOFA score; (2) Relative change (%) = [(post-treatment SOFA score - baseline SOFA score) / baseline SOFA score] × 100 |
Inclusion Criteria:
Exclusion Criteria:
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The study will be retrospective. Patients who received adjunctive hemoadsorption therapy at the Department of Anesthesiology and Intensive Care of Flór Ferenc Hospital between January 1, 2020, and May 31, 2026, will be included in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoltán Ruszkai, MD, PhD | Contact | 0036209151978 | ruszkai.zoltan@florhosp.hu | |
| Gergely Bokrétás, MD | Contact | bokretas.gergely@florhosp.hu |
| Name | Affiliation | Role |
|---|---|---|
| Zoltán Ruszkai, MD, PhD | Pest County Flór Ferenc Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pest County Flór Ferenc Hospital, Dept. of Anaesthesiology and Intensive Therapy | Recruiting | Kistarcsa | Pest County | 2143 | Hungary |
No identifiable individual participant data will be collected. All patient-level data will be anonymized, and no IPD will be made available for sharing.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2026 | Jun 25, 2026 | Prot_SAP_000.pdf |
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| Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy. |
| Shock Reversal Time (SRT) | Shock Reversal Time (SRT) is defined as the time from initiation of hemoadsorption therapy to sustained hemodynamic stabilization, according to predefined criteria. Hemodynamic stabilization is considered achieved when all of the following criteria are met: (1) vasopressor requirements have ceased or decreased to ≤10% of the maximum dose and are maintained for at least 3 consecutive hours, including norepinephrine and/or vasopressin; (2) for patients receiving multiple vasopressors, reduction of at least one vasopressor to ≤10% of its maximum dose is considered sufficient, provided that no increase in the dose of any other vasopressor is required; (3) Low-dose vasopressor support (≤10% of the maximum dose) may be continued if required to compensate for sedation or to maintain adequate organ perfusion; (4) in patients undergoing invasive hemodynamic monitoring, a cardiac index (CI) ≥2.5 L/min/m² is required; (5) arterial lactate ≤2 mmol/L; (6) ScvO₂ >70%; (7) dCO₂ < 7 mmHg | 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 | Changes in laboratory biomarkers will be assessed from baseline (immediately before initiation of hemoadsorption therapy) to immediately after treatment and 24 hours after completion of therapy. The following biomarkers will be evaluated: (1) arterial lactate; (2) Procalcitonin (PCT); (3) C-reactive protein (CRP); (4) Aspartate aminotransferase (ASAT); (5) Alanine aminotransferase (ALAT); (6) Total bilirubin. For each laboratory parameter, both absolute and relative changes will be calculated: (1) Absolute change = post-treatment value - baseline value; (2) Relative change (%) = [(post-treatment value - baseline value) / baseline value] × 100 | 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 | Changes in oxygenation will be assessed using the arterial oxygen partial pressure to inspired oxygen fraction ratio (PaO₂/FiO₂). Measurements will be obtained immediately before initiation of hemoadsorption therapy (baseline), immediately after completion of therapy, and 24 hours after completion of therapy. For the PaO₂/FiO₂ ratio, both absolute and relative changes will be calculated: (1) Absolute change = post-treatment value - baseline value; (2) Relative change (%) = [(post-treatment value - baseline value) / baseline value] × 100 | Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy. |
| Baseline (immediately before hemoadsorption therapy) and 24 hours after completion of hemoadsorption therapy. |
| Length of stay in the intensive care unit (ICU) | The duration of the patient's stay in the intensive care unit (days), measured from ICU admission to ICU discharge. | From ICU admission until ICU discharge (up to 90 days). |
| ICU mortality | ICU mortality is defined as all-cause death occurring during the patient's stay in the intensive care unit, regardless of the cause of death. | From ICU admission until ICU discharge (up to 90 days). |
| 28-day all-cause mortality | All-cause mortality occurring within 28 days after initiation of hemoadsorption therapy. | 28 days after initiation of hemoadsorption therapy. |
| 90-day all-cause mortality | All-cause mortality occurring within 90 days after initiation of hemoadsorption therapy. | 90 days after initiation of hemoadsorption therapy. |