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

Maj Brit N. Kjær*, 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 AhlstedtSøren Hoffmann, Morten H. Bestle, Louise Gyldensted, Lars Nebrich, Lene Russell, Marianne Vang, Christoffer Sølling, Anne C. Brøchner, Bodil S. Rasmussen, Anders Perner

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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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.

Original languageEnglish
JournalActa Anaesthesiologica Scandinavica
Volume64
Issue number3
Pages (from-to)410-416
ISSN0001-5172
DOIs
Publication statusPublished - Mar 2020

Keywords

  • cognitive function
  • follow-up
  • HRQoL
  • IV fluid therapy
  • patient important outcomes
  • randomised clincial trial

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