Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock
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
Hannover Medical School
274 participants
Feb 19, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria5
- Age < 18 or > 80 years
- Urogenital focus of infection
- Pregnancy
- Heparin-induced thrombocytopenia
- Known reaction against fresh frozen plasma (FFP)
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Interventions
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)
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NCT05726825