Multicenter Study on the Use of Therapeutic Plasma Exchange as an Additional Treatment for Septic Shock.
Descrizione riassuntiva dello studio
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)
Intervento studiato
Therapeutic Plasma Exchange (TPE)
(BASEC)
Malattie studiate
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)
Criteri di esclusione
- Age < 18 or > 80 years - Urogenital infection focus - Pregnant women - Heparin-induced thrombocytopenia - Known (allergic) reaction to frozen fresh plasma (FFP) (BASEC)
Luogo dello studio
Zurigo
(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)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Sascha David
+41 44 255 8653
sascha.david@clutterusz.chUniversitätsspital Zürich Institut für Intensivmedizin Rämistrasse 100 8091 Zürich
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
01.04.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
non disponibile
Disegno dello studio
non disponibile
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile