Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial: Protocol and statistical analysis plan

Tine Sylvest Meyhoff*, Peter Buhl Hjortrup, Morten Hylander Møller, 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, Manu L N G MalbrainChristian Ahlstedt, Søren Hoffmann, Morten Heiberg Bestle, Lars Nebrich, Lene Russell, Marianne Vang, Michael Lindhardt Rasmussen, Christoffer Sølling, Bodil Steen Rasmussen, Anne Craveiro Brøchner, Anders Perner


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Introduction: Intravenous (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. Methods: CLASSIC 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. Discussion: The CLASSIC trial results will provide important evidence to guide clinicians’ choice regarding the IV fluid therapy in adults with septic shock.

TidsskriftActa Anaesthesiologica Scandinavica
Udgave nummer9
Sider (fra-til)1262-1271
StatusUdgivet - okt. 2019

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