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

NCT05726825 · tracked via the Priya Life Science Germany tracker

Sponsor

Hannover Medical School

Phase

Not applicable

Started

2025-02-19

Last updated

2025-03-13

Condition(s) studied

Septic Shock

Investigational drug(s) / intervention(s)

Therapeutic Plasma Exchange (TPE)

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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)

Primary outcome measure(s)

28-day mortality — from randomization up to 28 days following randomization

Trial sites (25)

Facility	City	Region	Status
University Hospital Innsbruck	Innsbruck	Austria	Not Yet Recruiting
University Hospital Vienna	Vienna	Austria	Not Yet Recruiting
St. Joseph Hospital	Berlin	Germany	Not Yet Recruiting
University Hospital Berlin Charite	Berlin	Germany	Not Yet Recruiting
University Hospital Bonn	Bonn	Germany	Recruiting
Hospital Braunschweig	Braunschweig	Germany	Not Yet Recruiting
Hospital Bremerhaven	Bremerhaven	Germany	Not Yet Recruiting
Hospital Cologne Meerheim	Cologne	Germany	Not Yet Recruiting
University Hospital Cologne	Cologne	Germany	Not Yet Recruiting
University Hospital Erlangen	Erlangen	Germany	Not Yet Recruiting
University Hospital Essen	Essen	Germany	Not Yet Recruiting
University Hospital Halle	Halle	Germany	Active Not Recruiting
University Hospital Hamburg (UKE)	Hamburg	Germany	Not Yet Recruiting
Hannover Medical School Anesthesiology	Hanover	Germany	Recruiting
Hannover Medical School Internal Medicine	Hanover	Germany	Recruiting
University Hospital Heidelberg	Heidelberg	Germany	Not Yet Recruiting
University Hospital Jena	Jena	Germany	Not Yet Recruiting
University Hospital Kiel	Kiel	Germany	Not Yet Recruiting
Hospital Magdeburg	Magdeburg	Germany	Not Yet Recruiting
University Hospital Munich (TUM) Anesthesiology	Munich	Germany	Not Yet Recruiting
University Hospital Munich (TUM) Internal Medicine	Munich	Germany	Not Yet Recruiting
University Hospital Muenster Anesthesiology	Münster	Germany	Not Yet Recruiting
University Hospital Rostock	Rostock	Germany	Not Yet Recruiting
University Hospital Bern	Bern	Switzerland	Not Yet Recruiting
University Hospital Zurich	Zurich	Switzerland	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05726825 on ClinicalTrials.gov ↗ ← All trials in Germany