Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock

Recruiting now · Not applicable

Conditions studied: Septic Shock

In brief

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.

Key facts

Study ID

NCT05726825

Run by

Hannover Medical School

People needed

274

Starts

2025-02-19

Expected to finish

2028-04-01

Last updated by the study team

2025-03-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Age < 18 or > 80 years
• Urogenital focus of infection
• Pregnancy
• Heparin-induced thrombocytopenia
• Known reaction against fresh frozen plasma (FFP)

Where it is running

• Hannover Medical School Anesthesiology — Hanover, Germany (enrolling)
• Hannover Medical School Internal Medicine — Hanover, Germany (enrolling)
• University Hospital Bonn — Bonn, Germany (enrolling)
• University Hospital Berlin Charite — Berlin, 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
• 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 Innsbruck — Innsbruck, Austria
• University Hospital Zurich — Zurich, Switzerland
• University Hospital Vienna — Vienna, Austria
• St. Joseph Hospital — Berlin, Germany

Full record on ClinicalTrials.gov

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