Status:
SUSPENDED
Extracorporal Cytokin Removal in Septic Shock: a Prospective, Randomized, Multicenter Clinical Trial
Lead Sponsor:
University of Pecs
Conditions:
Septic Shock
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Sepsis and septic shock have mortality rates between 20-50%. When standard therapeutic measures fail to improve patients' condition, additional therapeutic alternatives are applied to reduce morbidity...
Eligibility Criteria
Inclusion
- Septic shock as defined by the Sepsis-3 criteria
- Septic shock both medical or surgical ethiology (except for re-operation)
- APACHE \> 25
- Mechanical ventilation
- Norepinephrine requirement ≥0.4 µg/kg/min for at least 30 minutes, when hypovolemia is highly unlikely as indicated by invasive hemodynamic measurements assessed by the attending physician
- Invasive hemodynamic monitoring to determine cardiac output and derived variables
- Procalcitonin level ≥ 10 ng/ml
- Inclusion within 6 - 24 hours after the onset of vasopressor need and after all standard therapeutic measures have been implemented without clinical improvement (i.e.: the shock is considered refractory)
Exclusion
- Patients under 18 years and over 80
- Lack of health insurance
- Pregnancy
- Standard guideline-based medical treatment not exhausted (detailed below at 3.6) standard medical therapy)
- End stage organ failure
- New York Heart Association Class IV.
- Chronic renal failure with eGFR \< 15 ml/min/1,73 m2
- End-stage liver disease (MELD score \>30, Child-Pugh score Class C
- Unlikely survival for 24 hours according to the attending physician
- Acute onset of hemato-oncological illness
- Post cardiopulmonary resuscitation care
- Re-operation in context with the septic insult
- Immunosuppression
- systemic steroid therapy (\>10 mg prednisolon/day)
- immunosuppressive agents (i.e.: methotrexate, azathioprine, cyclosporin, tacrolimus, cyclophosphamide)
- Human immunodeficiency virus infection (active AIDS): HIV-VL \> 50 copies/mL
- Patients with transplanted vital organs
- Thrombocytopenia (\<20.000/ml)
- More than 10%-of body surface area with a third-degree burn
- Acute coronary syndrome
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT04742764
Start Date
January 1 2024
End Date
October 31 2027
Last Update
April 20 2023
Active Locations (1)
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1
Institute for Translational Medicine, University of Pécs
Pécs, Hungary, 7624