Multicenter Study on the Use of Therapeutic Plasma Exchange as an Additional Treatment for Septic Shock.
Résumé de l'étude
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)
Intervention étudiée
Therapeutic Plasma Exchange (TPE)
(BASEC)
Maladie en cours d'investigation
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)
Critères d'exclusion
- Age < 18 or > 80 years - Urogenital infection focus - Pregnant women - Heparin-induced thrombocytopenia - Known (allergic) reaction to frozen fresh plasma (FFP) (BASEC)
Lieu de l’étude
Zurich
(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)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Sascha David
+41 44 255 8653
sascha.david@clutterusz.chUniversitätsspital Zürich Institut für Intensivmedizin Rämistrasse 100 8091 Zürich
(BASEC)
Informations scientifiques
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
01.04.2025
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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