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

M.B.N. Kjaer*, T.S. Meyhoff, M.B. Madsen, P.B. Hjortrup, M.H. Moller, I. Egerod, J. Wetterslev, T. Lange, M. Cronhjort, J.H. Laake, S.M. Jakob, M. Nalos, V. Pettila, I.C.C. van der Horst, M. Ostermann, P. Mouncey, M. Cecconi, R. Ferrer, M.L.N.G. Malbrain, C. AhlstedtS. Hoffmann, M.H. Bestle, L. Gyldensted, L. Nebrich, L. Russell, M. Vang, C. Solling, A.C. Brochner, B.S. Rasmussen, A. Perner

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

BackgroundIn 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.AimTo assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial.MethodsIn 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.DiscussionWith 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
Pages (from-to)410-416
Number of pages7
JournalActa Anaesthesiologica Scandinavica
Volume64
Issue number3
DOIs
Publication statusPublished - 1 Mar 2020

Keywords

  • clinical-research
  • cognitive function
  • follow-up
  • health
  • hrqol
  • impairment
  • intensive-care
  • iv fluid therapy
  • management
  • montreal cognitive assessment
  • patient important outcomes
  • quality-of-life
  • randomised clincial trial
  • respiratory-failure survivors
  • sepsis
  • strategies
  • MONTREAL COGNITIVE ASSESSMENT
  • RESPIRATORY-FAILURE SURVIVORS
  • IMPAIRMENT
  • STRATEGIES
  • HRQoL
  • QUALITY-OF-LIFE
  • HEALTH
  • IV fluid therapy
  • MANAGEMENT
  • SEPSIS
  • INTENSIVE-CARE
  • CLINICAL-RESEARCH

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