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Landiolol in patients with septic shock resident in an intensive care unit (LANDI-SEP): study protocol for a randomized controlled trial

M. Unger, A. Morelli, M. Singer, P. Radermacher, S. Rehberg, H. Trimmel, M. Joannidis, G. Heinz, V. Cerny, P. Dostál, C. Siebers, F. Guarracino, F. Pratesi, G. Biancofiore, M. Girardis, P. Kadlecova, O. Bouvet, M. Zörer, B. Grohmann-Izay, K....

. 2018 ; 19 (1) : 637. [pub] 20181119

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu protokol klinické studie, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc19028063

Grantová podpora
None Amomed Pharma GmbH

BACKGROUND: In patients with septic shock, the presence of an elevated heart rate (HR) after fluid resuscitation marks a subgroup of patients with a particularly poor prognosis. Several studies have shown that HR control in this population is safe and can potentially improve outcomes. However, all were conducted in a single-center setting. The aim of this multicenter study is to demonstrate that administration of the highly beta1-selective and ultrashort-acting beta blocker landiolol in patients with septic shock and persistent tachycardia (HR ≥ 95 beats per minute [bpm]) is effective in reducing and maintaining HR without increasing vasopressor requirements. METHODS: A phase IV, multicenter, prospective, randomized, open-label, controlled study is being conducted. The study will enroll a total of 200 patients with septic shock as defined by The Third International Consensus Definitions for Sepsis and Septic Shock criteria and tachycardia (HR ≥ 95 bpm) despite a hemodynamic optimization period of 24-36 h. Patients are randomized (1:1) to receive either standard treatment (according to the Surviving Sepsis Campaign Guidelines 2016) and continuous landiolol infusion to reach a target HR of 80-94 bpm or standard treatment alone. The primary endpoint is HR response (HR 80-94 bpm), the maintenance thereof, and the absence of increased vasopressor requirements during the first 24 h after initiating treatment. DISCUSSION: Despite recent studies, the role of beta blockers in the treatment of patients with septic shock remains unclear. This study will investigate whether HR control using landiolol is safe, feasible, and effective, and further enhance the understanding of beta blockade in patients with septic shock. TRIAL REGISTRATION: EU Clinical Trials Register; EudraCT, 2017-002138-22 . Registered on 8 August 2017.

Aixial s r o Brno Czech Republic

Amomed Pharma GmbH Vienna Austria

AOP Orphan Pharmaceuticals AG Wilhelminenstraße 91 2 f 1160 Vienna Austria

Department of Anesthesia and Intensive Care University Hospital of Modena Modena Italy

Department of Anesthesiology and Intensive Care University Hospital La Sapienza Policlinico Umberto 1 Rome Italy

Department of Anesthesiology and Resuscitation 5 Azienda Ospedaliero Universitaria Pisana Pisa Italy

Department of Anesthesiology and Resuscitation 6 Azienda Ospedaliero Universitaria Pisana Pisa Italy

Department of Anesthesiology Emergency Medicine and General Intensive Care State Hospital Wiener Neustadt Wiener Neustadt Austria

Department of Anesthesiology Intensive Care Emergency and Pain Medicine University Hospital Greifswald Greifswald Germany

Department of Anesthesiology Perioperative Medicine and Intensive Care Masaryk Hospital Usti Nad Labem Czech Republic

Department of Anesthesiology Resuscitation and Intensive Medicine University Hospital Hradec Králové Hradec Králové Czech Republic

Department of Anesthesiology University Hospital Munich Munich Germany

Department of Internal Medicine 2 Division of Cardiology Intensive Care Unit Medical University General Hospital Vienna Austria

Division of Emergency Medicine and Intensive Care Department Internal Medicine Medical University Innsbruck Innsbruck Austria

Division of Transplant Anesthesia and Critical Care University School of Medicine Pisa Pisa Italy

Institute of Anesthesiologic Pathophysiology and Process Engineering Ulm University Hospital Ulm Germany

Intensive Care Medicine University College London London UK

Citace poskytuje Crossref.org

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