Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

Study Overview
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Brief Summary
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The aim of the study is to investigate the effect of CytoSorb® treatment within the first 48 hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as monitored by leukocyte activation and inflammatory mediators.

Official Title
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The Effect of Early Cytokine Absorption on the Systemic Inflammatory Response Syndrome and Organ Dysfunction in the First 48 Hours of Septic Shock

Conditions
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Sepsis, Septic Shock

Intervention / Treatment
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* Device: CytoSorb 300ml device (3804606CE01)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signs of hypoperfusion: serum lactate >2 mmol/L, low central venous oxygen saturation (ScvO2) (<70%) or high ScvO2 (>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 >6 mm Hg) Hemodynamic support with vasopressors Procalcitonin level ≥ 3 ng/ml Invasive hemodynamic monitoring Written informed content Exclusion Criteria: Patients under 18 years Pregnancy (bHCG test positivity) Surgical intervention in context with the septic insult New York Heart Association IV heart failure Acute coronary syndrome Need for acute or chronic hemodialysis Acute haematological malignancies Cardiogenic shock Post cardiopulmonary resuscitation care Immunosuppression, systemic steroid therapy (>10mg prednisolon/day) Human immunodeficiency virus infection (HIV) and active AIDS Patients with donated organs Thrombocytopenia (<20.000/ml) More than 10%-of body surface area with third degree burn

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CytoSorb<br>Patients with septic shock will get routine ICU care supported by CytoSorb® treatment. | Device: CytoSorb 300ml device (3804606CE01)<br> <br> |
| Control<br>Patients with septic shock will get routine ICU care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine response | Cytokine response: procalcitonin, C-reactive protein, interleukin-1, interleukin-1ra, interleukin-6, interleukin-8, interleukin-10, Tumor Necrosis Factor- α | First 48 hours of septic shock | 
| Organ dysfunctions | Organ dysfunctions: SOFA-scores, neurologic function (Glasgow coma scale), hemodynamic function (PiCCO parameters, ScvO2, lactate, dCO2), pulmonary function (gas exchange, pulmonary mechanics, Acute Respiratory Distress Syndrome classification (BERLIN)), renal function (KDIGO-, RIFLE-scores), gastrointestinal function (liver, GIT function, hematology (hemostasis, qualitative blood count) | First 48 hours of septic shock | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte function | Leukocyte function: heterogeneity of leukocyte cell population in the bloodstream, T-cell activation and apoptosis, leukocyte inflammatory markers expression | First 48 hours of septic shock | 
| Microcirculation | Microcirculation: orthogonal polarization spectroscopy (OPS), gastric tonometry | First 48 hours of septic shock | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemoadsorption, extracorporeal blood purification, CytoSorb, hemofiltration, SIRS, sepsis, septic shock, membranes, ICU, dialysis, adsorption