Hemodynamic, Laboratory, and Clinical Outcomes of Hemoadsorption Therapy

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)

Time frame: 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

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

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

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

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

Time frame: Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy.