Efficacy of add-on Plasma Exchange as an Adjunctive Strategy Against Septic Shock (EXCHANGE-2)
Septic Shock
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring Septic Shock, Sepsis, Multi-organ failure, Extracorporeal therapy, Plasmapheresis
Eligibility Criteria
Inclusion Criteria: New onset of septic shock (< 24 hrs), (SEPSIS-3 definition) Norepinephrine (NE) dose ≥ 0.4 μg/kg/min ≥ 30 min OR NE ≥ 0.3 μg/kg/min + vasopressin (any dose) Established vascular access suitable for plasma exchange independent of study inclusion (due to established indication of RRT, expected need for RRT within the next 48 hours or other medical reasons as assessed by treating physician team) Exclusion Criteria: Age < 18 or > 80 years Urogenital focus of infection Pregnancy Heparin-induced thrombocytopenia Known reaction against fresh frozen plasma (FFP)
Sites / Locations
- University Hospital Innsbruck
- University Hospital Vienna
- St. Joseph Hospital
- University Hospital Berlin Charite
- University Hospital Bonn
- Hospital Braunschweig
- Hospital Bremerhaven
- Hospital Cologne Meerheim
- University Hospital Cologne
- University Hospital Erlangen
- University Hospital Essen
- University Hospital Halle
- University Hospital Hamburg (UKE)
- Hannover Medical School Anesthesiology
- Hannover Medical School Internal Medicine
- University Hospital Heidelberg
- University Hospital Jena
- University Hospital Kiel
- Hospital Magdeburg
- University Hospital Muenster Anesthesiology
- University Hospital Munich (TUM) Anesthesiology
- University Hospital Munich (TUM) Internal Medicine
- University Hospital Rostock
- University Hospital Bern
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Therapeutic Plasma Exchange (TPE)
Standard of Care (SOC)
1 x TPE with donor Fresh Frozen Plasma (FFPs) (1.2 x individual plasma volume) within the first 6 hrs after randomization. A second TPE can be performed if the patient remains vasopressor dependent ≥ 0.4 ug/kg/min within 24 hours after the first intervention.
Non-interventional standard of care