Status:
COMPLETED
Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study
Lead Sponsor:
Zsolt Molnár, MD, PhD, DEAA
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
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 leuk...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02288975
Start Date
October 1 2014
End Date
December 1 2017
Last Update
March 27 2018
Active Locations (1)
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1
Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád megye, Hungary, H-6725