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. 2020 Mar;64(3):410-416.
doi: 10.1111/aas.13519. Epub 2019 Dec 26.

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

Maj-Brit N Kjaer  1   2 , Tine S Meyhoff  1   2 , Martin B Madsen  1 , Peter B Hjortrup  1 , Morten Hylander Møller  1   2 , Ingrid Egerod  1   2 , Jørn Wetterslev  2   3 , Theis Lange  4 , Maria Cronhjort  5 , Jon H Laake  6 , Stephan M Jakob  7 , Marek Nalos  8 , Ville Pettilä  9 , Iwan C C van der Horst  10 , Marlies Ostermann  11 , Paul Mouncey  12 , Maurizio Cecconi  13 , Ricard Ferrer  14 , Manu L N G Malbrain  15   16 , Christian Ahlstedt  17 , Søren Hoffmann  18 , Morten H Bestle  19   20 , Louise Gyldensted  21 , Lars Nebrich  22 , Lene Russell  23   24 , Marianne Vang  25 , Christoffer Sølling  26 , Anne C Brøchner  27 , Bodil S Rasmussen  2   28 , Anders Perner  1   2
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Free article

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

Maj-Brit N Kjaer et al. Acta Anaesthesiol Scand. 2020 Mar.
Free article

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.

Trial registration: ClinicalTrials.gov NCT03668236.

Keywords: HRQoL; IV fluid therapy; cognitive function; follow-up; patient important outcomes; randomised clincial trial.

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  • Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock.
    Kjær MN, Meyhoff TS, Sivapalan P, Granholm A, Hjortrup PB, Madsen MB, Møller MH, Egerod I, Wetterslev J, Lange T, Cronhjort M, Laake JH, Jakob SM, Nalos M, Ostermann M, Gould D, Cecconi M, Malbrain MLNG, Ahlstedt C, Kiel LB, Bestle MH, Nebrich L, Hildebrandt T, Russell L, Vang M, Rasmussen ML, Sølling C, Brøchner AC, Krag M, Pfortmueller C, Kriz M, Siegemund M, Albano G, Aagaard SR, Bundgaard H, Crone V, Wichmann S, Johnstad B, Martin YK, Seidel P, Mårtensson J, Hollenberg J, Wistrand M, Donati A, Barbara E, Karvunidis T, Hollinger A, Carsetti A, Lumlertgul N, Joelsson-Alm E, Lambiris N, Aslam TN, Friberg FF, Vesterlund GK, Mortensen CB, Vestergaard SR, Caspersen SF, Jensen DB, Borup M, Rasmussen BS, Perner A. Kjær MN, et al. Intensive Care Med. 2023 Jul;49(7):820-830. doi: 10.1007/s00134-023-07114-8. Epub 2023 Jun 18. Intensive Care Med. 2023. PMID: 37330928 Free PMC article.

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