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Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial : GENIUS-Gelatine use in ICU and sepsis

G. Marx, K. Zacharowski, C. Ichai, K. Asehnoune, V. Černý, R. Dembinski, R. Ferrer Roca, D. Fries, Z. Molnar, P. Rosenberger, M. Sanchez-Sanchez, T. Schürholz, T. Dehnhardt, S. Schmier, E. von Kleist, U. Brauer, TP. Simon

. 2021 ; 22 (1) : 376. [pub] 20210602

Jazyk angličtina Země Velká Británie

Typ dokumentu protokol klinické studie, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc21018473

BACKGROUND: Sepsis is associated with capillary leakage and vasodilatation and leads to hypotension and tissue hypoperfusion. Early plasma volume replacement is required to achieve haemodynamic stability (HDS) and maintain adequate tissue oxygenation. The right choice of fluids to be used for plasma volume replacement (colloid or crystalloid solutions) is still a matter of debate, and large trials investigating the use of colloid solutions containing gelatine are missing. This study aims to investigate the efficacy and safety of plasma volume replacement using either a combined gelatine-crystalloid regime (1:1 ratio) or a pure crystalloid regime. METHODS: This is a prospective, controlled, randomized, double-blind, international, multicentric phase IV study with two parallel groups that is planned to be conducted at European intensive care units (ICUs) in a population of patients with hypovolaemia in severe sepsis/septic shock. A total of 608 eligible patients will be randomly assigned to receive either a gelatine-crystalloid regime (Gelaspan® 4% and Sterofundin® ISO, B. Braun Melsungen AG, in a 1:1 ratio) or a pure crystalloid regime (Sterofundin® ISO) for plasma volume replacement. The primary outcome is defined as the time needed to achieve HDS. Plasma volume replacement will be target-controlled, i.e. fluids will only be administered to volume-responsive patients. Volume responsiveness will be assessed through passive leg raising or fluid challenges. The safety and efficacy of both regimens will be assessed daily for 28 days or until ICU discharge (whichever occurs first) as the secondary outcomes of this study. Follow-up visits/calls will be scheduled on day 28 and day 90. DISCUSSION: This study aims to generate evidence regarding which regimen-a gelatine-crystalloid regimen or a pure crystalloid regimen-is more effective in achieving HDS in critically ill patients with hypovolaemia. Study participants in both groups will benefit from the increased safety of target-controlled plasma volume replacement, which prevents fluid administration to already haemodynamically stable patients and reduces the risk of harmful fluid overload. TRIAL REGISTRATION: The European clinical trial database EudraCT 2015-000057-20 and the ClinicalTrials.gov Protocol Registration and Results System ClinicalTrials.gov NCT02715466 . Registered on 17 March 2016.

Allgemeine und Chirurgische Intensivstation Medizinische Universität Innsbruck Anichstraße 35 6020 Innsbruck Austria

Faculty of Medicine Department of Anaesthesiology and Intensive Therapy Poznan University for Medical Sciences 49 Przybyszewskiego St 60 355 Poznan Poland

Hospital Universitario La Paz Cantoblanco Carlos 3 Hospital La Paz Institute for Health Research Paseo de la Castellana 261 28046 Madrid Spain

Klinik für Anästhesiologie Intensivmedizin und Schmerztherapie Universitätsklinikum Frankfurt Main Goethe Universität Theodor Stern Kai 7 60590 Frankfurt Main Germany

Klinik für Intensivmedizin und Notfallmedizin Klinikum Bremen Mitte St Jürgen Straße 1 28177 Bremen Germany

Klinik für Operative Intensivmedizin und Intermediate Care Universitätsklinikum RWTH Aachen Pauwelsstraße 30 52074 Aachen Germany

Klinik und Poliklinik für Anästhesiologie und Intensivtherapie Universitätsmedizin Rostock Schillingallee 35 18057 Rostock Germany

Krajská zdravotní a s Masarykova nemocnice v Ústí nad Labem o z Sociální péče 3316 12A 401 13 Ústí nad Labem Czech Republic

Medical Scientific Affairs B Braun Melsungen AG Carl Braun Straße 1 34212 Melsungen Germany

School of Medicine Institute for Translational Medicine University of Pécs 12 Szigeti St Pécs 7624 Hungary

Servicio de Medicina Intensiva Hospital Universitari Vall d'Hebron Passeig Vall d'Hebron 119 129 08035 Barcelona Spain

Universitätsklinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Tübingen Hoppe Seyler Straße 3 72076 Tübingen Germany

Université Côte d'Azur Service de Réanimation Polyvalente Hôpital Pasteur 2 CHU de Nice 30 Voie Romaine 06000 Nice France

Université de Nantes CHU L'Hôtel Dieu 1 Place Alexis Ricordeau 44093 Nantes Cedex 1 France

Citace poskytuje Crossref.org

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