Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

Zsolt Molnár, MD, PhD, DEAA

Status: Completed

Conditions: Septic Shock; Sepsis

Treatments: Device: CytoSorb 300ml device (3804606CE01)

Study type: Observational

Funder types: Other

Identifiers

NCT02288975

CytoSorb-2014

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

20 participants in 2 patient groups

CytoSorb

Description:

Patients with septic shock will get routine ICU care supported by CytoSorb® treatment.

Treatment:

Device: CytoSorb 300ml device (3804606CE01)

Control

Description:

Patients with septic shock will get routine ICU care.