Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02288975

Enrollment

Registered

2014-11-13

Start date

2014-10-31

Completion date

2017-12-31

Last updated

2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock

Keywords

hemoadsorption, extracorporeal blood purification, CytoSorb, hemofiltration, SIRS, sepsis, septic shock, membranes, ICU, dialysis, adsorption

Brief summary

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.

Interventions

DEVICECytoSorb 300ml device (3804606CE01)

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Organ dysfunctions	First 48 hours of septic shock	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)
Cytokine response	First 48 hours of septic shock	Cytokine response: procalcitonin, C-reactive protein, interleukin-1, interleukin-1ra, interleukin-6, interleukin-8, interleukin-10, Tumor Necrosis Factor- α

Secondary

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

Other

Measure	Time frame
Length of hospital stay	First 48 hours of septic shock
Length of intensive care unit stay,	First 48 hours of septic shock
Mortality	First 48 hours of septic shock

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026