Long-term patient-important outcomes after septic shock: A protocol for 1-year follow-up of the CLASSIC trial

Maj-Brit N Kjaer, Tine S Meyhoff, Martin B Madsen, Peter B Hjortrup, Morten Hylander Møller, Ingrid Egerod, Jørn Wetterslev, Theis Lange, Maria Cronhjort, Jon H Laake, Stephan M Jakob, Marek Nalos, Ville Pettilä, Iwan C C van der Horst, Marlies Ostermann, Paul Mouncey, Maurizio Cecconi, Ricard Ferrer, Manu L N G Malbrain, Christian Ahlstedt, Søren Hoffmann, Morten H Bestle, Louise Gyldensted, Lars Nebrich, Lene Russell, Marianne Vang, Christoffer Sølling, Anne C Brøchner, Bodil S Rasmussen, Anders Perner, Maj-Brit N Kjaer, Tine S Meyhoff, Martin B Madsen, Peter B Hjortrup, Morten Hylander Møller, Ingrid Egerod, Jørn Wetterslev, Theis Lange, Maria Cronhjort, Jon H Laake, Stephan M Jakob, Marek Nalos, Ville Pettilä, Iwan C C van der Horst, Marlies Ostermann, Paul Mouncey, Maurizio Cecconi, Ricard Ferrer, Manu L N G Malbrain, Christian Ahlstedt, Søren Hoffmann, Morten H Bestle, Louise Gyldensted, Lars Nebrich, Lene Russell, Marianne Vang, Christoffer Sølling, Anne C Brøchner, Bodil S Rasmussen, Anders Perner

Abstract

Background: In 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.

Aim: To assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial.

Methods: In 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.

Discussion: With 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.

Trial registration: ClinicalTrials.gov NCT03668236.

Keywords: HRQoL; IV fluid therapy; cognitive function; follow-up; patient important outcomes; randomised clincial trial.

© 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

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