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
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Austria
University Hospital Innsbruck
NOT_YET_RECRUITING
Innsbruck
University Hospital Vienna
NOT_YET_RECRUITING
Vienna
Germany
St. Joseph Hospital
NOT_YET_RECRUITING
Berlin
University Hospital Berlin Charite
NOT_YET_RECRUITING
Berlin
University Hospital Bonn
RECRUITING
Bonn
Hospital Braunschweig
NOT_YET_RECRUITING
Braunschweig
Hospital Bremerhaven
NOT_YET_RECRUITING
Bremerhaven
Hospital Cologne Meerheim
NOT_YET_RECRUITING
Cologne
University Hospital Cologne
NOT_YET_RECRUITING
Cologne
University Hospital Erlangen
NOT_YET_RECRUITING
Erlangen
University Hospital Essen
NOT_YET_RECRUITING
Essen
University Hospital Halle
ACTIVE_NOT_RECRUITING
Halle
University Hospital Hamburg (UKE)
NOT_YET_RECRUITING
Hamburg
Hannover Medical School Anesthesiology
RECRUITING
Hanover
Hannover Medical School Internal Medicine
RECRUITING
Hanover
University Hospital Heidelberg
NOT_YET_RECRUITING
Heidelberg
University Hospital Jena
NOT_YET_RECRUITING
Jena
University Hospital Kiel
NOT_YET_RECRUITING
Kiel
Hospital Magdeburg
NOT_YET_RECRUITING
Magdeburg
University Hospital Munich (TUM) Anesthesiology
NOT_YET_RECRUITING
Munich
University Hospital Munich (TUM) Internal Medicine
NOT_YET_RECRUITING
Munich
University Hospital Muenster Anesthesiology
NOT_YET_RECRUITING
Münster
University Hospital Rostock
NOT_YET_RECRUITING
Rostock
Switzerland
University Hospital Bern
NOT_YET_RECRUITING
Bern
University Hospital Zurich
NOT_YET_RECRUITING
Zurich
Contact Information
Primary
Sascha David, Prof. Dr.
sascha.david@usz.ch
+41 44 255 8653
Backup
Klaus Stahl, PD Dr.
stahl.klaus@mh-hannover.de
+49 (0)176 1532 8277
Time Frame
Start Date: 2025-02-19
Estimated Completion Date: 2028-04
Participants
Target number of participants: 274
Treatments
Experimental: Therapeutic Plasma Exchange (TPE)
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.
No_intervention: Standard of Care (SOC)
Non-interventional standard of care
Related Therapeutic Areas
Sponsors
Leads: Hannover Medical School