• Maj-Brit N Kjaer, Tine S Meyhoff, Martin B Madsen, Peter B Hjortrup, MøllerMorten HylanderMH0000-0002-6378-9673Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark., Ingrid Egerod, Jørn Wetterslev, Theis Lange, Maria Cronhjort, Jon H Laake, Stephan M Jakob, Marek Nalos, Ville Pettilä, van der HorstIwan C CICCDepartment of Intensive Care, Maastricht University Medical Center+, University Maastricht, Maastrict, The Netherlands., Marlies Ostermann, Paul Mouncey, Maurizio Cecconi, Ricard Ferrer, MalbrainManu L N GMLNGDepartment of Intensive Care Medicine, University Hospital Brussels (UZB), Jette, Belgium.Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel (VUB), Brussels, Belgium., Christian Ahlstedt, Søren Hoffmann, Morten H Bestle, Louise Gyldensted, Lars Nebrich, Lene Russell, Marianne Vang, Christoffer Sølling, Anne C Brøchner, Bodil S Rasmussen, and Anders Perner.
• Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
• Acta Anaesthesiol Scand. 2020 Mar 1; 64 (3): 410416410-416.

BackgroundIn patients with septic shock, mortality is high, and survivors experience long-term physical, mental and social impairments. The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard-care intravenous (IV) fluid therapy. The hypothesis is that IV fluid restriction improves patient-important long-term outcomes.AimTo assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial.MethodsIn this pre-planned follow-up study of the CLASSIC trial, we will assess all-cause mortality, health-related quality of life (HRQoL) and cognitive function 1 year after randomisation in the two intervention groups. The 1-year mortality will be collected from electronic patient records or central national registries in most participating countries. We will contact survivors and assess EuroQol 5-Dimension, -5-Level (EQ-5D-5L) and EuroQol-Visual Analogue Scale and Montreal Cognitive Assessment 5-minute protocol score. We will analyse mortality by logistic regression and use general linear models to assess HRQoL and cognitive function.DiscussionWith this pre-planned follow-up study of the CLASSIC trial, we will provide patient-important data on long-term survival, HRQoL and cognitive function of restrictive vs standard-care IV fluid therapy in patients with septic shock.© 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

23 keywords...

hide…