Hemodynamic, Laboratory, and Clinical Outcomes 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)

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)

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

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

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

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

The duration of the patient's stay in the intensive care unit (days), measured from ICU admission to ICU discharge.

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.

All-cause mortality occurring within 28 days after initiation of hemoadsorption therapy.

All-cause mortality occurring within 90 days after initiation of hemoadsorption therapy.