TY - JOUR
T1 - Long-term patient-important outcomes after septic shock
T2 - a protocol for 1-year follow-up of the CLASSIC-trial
AU - Kjaer, Maj-Brit Nørregaard
AU - Meyhoff, Tine Sylvest
AU - Madsen, Martin Bruun
AU - Hjortrup, Peter Buhl
AU - Møller, Morten Hylander
AU - Egerod, Ingrid
AU - Wetterslev, Jørn
AU - Lange, Theis
AU - Cronhjort, Maria
AU - Laake, Jon Henrik
AU - Jakob, Stephan M
AU - Nalos, Marek
AU - Pettilä, Ville
AU - van der Horst, Iwan C C
AU - Ostermann, Marlies
AU - Mouncey, Paul
AU - Cecconi, Maurizio
AU - Ferrer, Ricard
AU - L N G Malbrain, Manu
AU - Ahlstedt, Christian
AU - Hoffmann, Søren
AU - Bestle, Morten H
AU - Gyldensted, Louise
AU - Nebrich, Lars
AU - Russell, Lene
AU - Vang, Marianne
AU - Sølling, Christoffer
AU - Brøchner, Anne Craveiro
AU - Rasmussen, Bodil Steen
AU - Perner, Anders
N1 - � 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.
PY - 2020/3
Y1 - 2020/3
N2 - 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.
AB - 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.
KW - cognitive function
KW - follow-up
KW - HRQoL
KW - IV fluid therapy
KW - patient important outcomes
KW - randomised clincial trial
U2 - 10.1111/aas.13519
DO - 10.1111/aas.13519
M3 - Protocol
C2 - 31828753
SN - 0001-5172
VL - 64
SP - 410
EP - 416
JO - Acta Anaesthesiologica Scandinavica
JF - Acta Anaesthesiologica Scandinavica
IS - 3
ER -