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- Title
Long-term patient-important outcomes after septic shock: A protocol for 1-year follow-up of the CLASSIC trial.
- Authors
Kjær, Maj‐Brit N.; Meyhoff, Tine S.; Madsen, Martin B.; Hjortrup, Peter B.; Møller, Morten Hylander; Egerod, Ingrid; Wetterslev, Jørn; Lange, Theis; Cronhjort, Maria; Laake, Jon H.; Jakob, Stephan M.; Nalos, Marek; Pettilä, Ville; van der Horst, Iwan C. C.; Ostermann, Marlies; Mouncey, Paul; Cecconi, Maurizio; Ferrer, Ricard; Malbrain, Manu L. N. G.; Ahlstedt, Christian
- Abstract
<bold>Background: </bold>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.<bold>Aim: </bold>To assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial.<bold>Methods: </bold>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.<bold>Discussion: </bold>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.
- Subjects
SEPTIC shock; MONTREAL Cognitive Assessment; FLUID therapy; INTRAVENOUS therapy; SHOCK therapy; EXPERIMENTAL design; TIME; QUALITY of life; RESEARCH funding; LONGITUDINAL method; DISEASE complications
- Publication
Acta Anaesthesiologica Scandinavica, 2020, Vol 64, Issue 3, p410
- ISSN
0001-5172
- Publication type
journal article
- DOI
10.1111/aas.13519