Multicenter Study on the Use of Therapeutic Plasma Exchange as an Additional Treatment for Septic Shock.
Zusammenfassung der Studie
So far, there have been few specific treatment options for your condition, septic shock. Our treatment strategies focus on the following aspects: 1. Anti-infectives (which can include antibiotics), 2. Circulatory stabilization (using fluids or circulatory-active medications, known as catecholamines), and 3. Organ replacement procedures (artificial ventilation, dialysis, etc.). Sepsis is an overreaction of the body to an infection. However, there is still no specific treatment for this dangerous overreaction. We hope that conducting the planned clinical study will provide a protective effect on this aspect of the disease. In addition to standard therapy, a so-called Therapeutic Plasma Exchange (TPE) will take place; this involves exchanging the patient's plasma for healthy donor plasma. The scientific idea behind this method is relatively simple and is based on the attempt to remove harmful factors circulating in the blood, essentially a kind of blood cleansing. The TPE is performed with a corresponding machine, similar to blood washing, and takes about 2 hours. This procedure has been routinely established for other diseases for decades and is regularly performed in large centers (e.g., approximately 500 such treatments are performed annually at USZ, which is more than 1 treatment per day). The spectrum of side effects is low and usually not severe. They mainly consist of allergic reactions and drops in blood pressure, which can be detected early in an intensive care unit and thus treated quickly and effectively. The overarching goal of the study is to demonstrate a survival advantage for patients treated with TPE compared to standard therapy after 28 days.
(BASEC)
Untersuchte Intervention
Therapeutic Plasma Exchange (TPE)
(BASEC)
Untersuchte Krankheit(en)
Septic Shock
(BASEC)
- Newly occurring septic shock (< 24 hours), (SEPSIS-3 definition) - Norepinephrine (NE) dose ≥ 0.4 μg/kg/min for ≥ 30 min OR NE ≥ 0.3 μg/kg/min + Vasopressin (any dose) - Established vascular access that is indicated for plasma exchange independent of study enrollment (due to an established indication for RRT, an expected need for RRT within the next 48 hours, or for other medical reasons assessed by the treating physician team) (BASEC)
Ausschlusskriterien
- Age < 18 or > 80 years - Urogenital infection focus - Pregnant women - Heparin-induced thrombocytopenia - Known (allergic) reaction to frozen fresh plasma (FFP) (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Medizinische Hochschule Hannover Carl-Neuberg-Str. 1 30625 Hannover; Sponsor Representative Switzerland Prof. Dr. med. Sascha David Universitätsspital Zürich Institut für Intensivmedizin Rämistrasse 100 8091 Zürich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Sascha David
+41 44 255 8653
sascha.david@clutterusz.chUniversitätsspital Zürich Institut für Intensivmedizin Rämistrasse 100 8091 Zürich
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
01.04.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
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 (EXCHANGE-2) (BASEC)
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