• Tine Sylvest Meyhoff, Peter Buhl Hjortrup, Møller Morten Hylander MH 0000-0002-6378-9673 Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. , Jørn Wetterslev, Theis Lange, Maj-Brit Nørregaard Kjaer, Andreas Bender Jonsson, Carl Johan Steensen Hjortsø, Maria Cronhjort, Jon Henrik Laake, Stephan M Jakob, Marek Nalos, Ville Pettilä, Iwan van der Horst, Marlies Ostermann, Paul Mouncey, Kathy Rowan, Maurizio Cecconi, Ricard Ferrer, Malbrain Manu L N G MLNG Department of Intensive Care Medicine, University Hospital Brussels (UZB), Jette, Belgium. , Christian Ahlstedt, Søren Hoffmann, Morten Heiberg Bestle, Lars Nebrich, Lene Russell, Marianne Vang, Michael Lindhardt Rasmussen, Christoffer Sølling, Bodil Steen Rasmussen, Anne Craveiro Brøchner, and Anders Perner.
• Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
• Acta Anaesthesiol Scand. 2019 Oct 1; 63 (9): 1262-1271.

IntroductionIntravenous (IV) fluid is a key intervention in the management of septic shock. The benefits and harms of lower versus higher fluid volumes are unknown and thus clinical equipoise exists. We describe the protocol and detailed statistical analysis plan for the conservative versus liberal approach to fluid therapy of septic shock in the Intensive Care (CLASSIC) trial. The aim of the CLASSIC trial is to assess benefits and harms of IV fluid restriction versus standard care in adult intensive care unit (ICU) patients with septic shock.MethodsCLASSIC trial is an investigator-initiated, international, randomised, stratified, and analyst-blinded trial. We will allocate 1554 adult patients with septic shock, who are planned to be or are admitted to an ICU, to IV fluid restriction versus standard care. The primary outcome is mortality at day 90. Secondary outcomes are serious adverse events (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), and cognitive function at 1 year. We will conduct the statistical analyses according to a pre-defined statistical analysis plan, including three interim analyses. For the primary analysis, we will use logistic regression adjusted for the stratification variables comparing the two interventions in the intention-to-treat (ITT) population.DiscussionThe CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock.© 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

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