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Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock
Sponsor: Hannover Medical School
Summary
Randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of therapeutic plasma exchange in patients with early septic shock.
Official title: Randomized, Prospective, Multicenter, Open-label, Controlled, Parallel-group Trial Investigating the Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock - 2
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
274
Start Date
2025-02-19
Completion Date
2028-04
Last Updated
2025-03-13
Healthy Volunteers
No
Conditions
Interventions
Therapeutic Plasma Exchange (TPE)
The TPE treatment will be initiated within 6 hrs after randomization. Duration of TPE treatment is approximately 120-180 minutes. An additional second TPE can be performed if the patient remains vasopressor dependent ≥ 0.4 ug/kg/min after 24 hours following the first TPE procedure. Both unfractionated heparin (UFH) and citrate may be used as anticoagulant medication. To ensure treatment comparability between different patients, we will replace plasma in a fixed ratio of 1.2 x the individual patient's total plasma fluid.
Locations (25)
University Hospital Innsbruck
Innsbruck, Austria
University Hospital Vienna
Vienna, Austria
St. Joseph Hospital
Berlin, Germany
University Hospital Berlin Charite
Berlin, Germany
University Hospital Bonn
Bonn, Germany
Hospital Braunschweig
Braunschweig, Germany
Hospital Bremerhaven
Bremerhaven, Germany
Hospital Cologne Meerheim
Cologne, Germany
University Hospital Cologne
Cologne, Germany
University Hospital Erlangen
Erlangen, Germany
University Hospital Essen
Essen, Germany
University Hospital Halle
Halle, Germany
University Hospital Hamburg (UKE)
Hamburg, Germany
Hannover Medical School Anesthesiology
Hanover, Germany
Hannover Medical School Internal Medicine
Hanover, Germany
University Hospital Heidelberg
Heidelberg, Germany
University Hospital Jena
Jena, Germany
University Hospital Kiel
Kiel, Germany
Hospital Magdeburg
Magdeburg, Germany
University Hospital Munich (TUM) Anesthesiology
Munich, Germany
University Hospital Munich (TUM) Internal Medicine
Munich, Germany
University Hospital Muenster Anesthesiology
Münster, Germany
University Hospital Rostock
Rostock, Germany
University Hospital Bern
Bern, Switzerland
University Hospital Zurich
Zurich, Switzerland