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

Kjaer, Maj-Brit Nørregaard; Meyhoff, Tine Sylvest; Madsen, Martin Bruun; Hjortrup, Peter Buhl; Møller, Morten Hylander; Egerod, Ingrid; Wetterslev, Jørn; Lange, Theis; Cronhjort, Maria; Laake, Jon Henrik; Jakob, Stephan M.; Nalos, Marek; Pettilä, Ville; van der Horst, Iwan C C; Ostermann, Marlies; Mouncey, Paul; Cecconi, Maurizio; Ferrer, Ricard; L N G Malbrain, Manu; Ahlstedt, Christian; ... (2020). Long-term patient-important outcomes after septic shock: a protocol for 1-year follow-up of the CLASSIC-trial. Acta anaesthesiologica Scandinavica, 64(3), pp. 410-416. Wiley-Blackwell 10.1111/aas.13519

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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 versus (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 one 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.

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