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Long-term patient-important outcomes after septic shock: A protocol for 1-year follow-up of the CLASSIC trial
MN. Kjaer, TS. Meyhoff, MB. Madsen, PB. Hjortrup, MH. Møller, I. Egerod, J. Wetterslev, T. Lange, M. Cronhjort, JH. Laake, SM. Jakob, M. Nalos, V. Pettilä, ICC. van der Horst, M. Ostermann, P. Mouncey, M. Cecconi, R. Ferrer, MLNG. Malbrain, C....
Jazyk angličtina Země Velká Británie
Typ dokumentu časopisecké články, práce podpořená grantem
PubMed
31828753
DOI
10.1111/aas.13519
Knihovny.cz E-zdroje
- MeSH
- čas MeSH
- dospělí MeSH
- kognitivní dysfunkce etiologie MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- přežívající statistika a číselné údaje MeSH
- septický šok komplikace mortalita MeSH
- výzkumný projekt * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
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.
Centre for Research in Intensive Care Copenhagen Denmark
Clinical Trial Unit Intensive Care National Audit and Research Centre London UK
Copenhagen Academy for Medical Education and Simulation Rigshospitalet Copenhagen Denmark
Department of Anaesthesia and Intensive Care Aalborg University Hospital Aalborg Denmark
Department of Anaesthesia and Intensive Care Lillebaelt Hospital Kolding Denmark
Department of Anaesthesia and Intensive Care Randers Hospital Randers Denmark
Department of Anaesthesia and Intensive Care Viborg Hospital Viborg Denmark
Department of Anaesthesia and Intensive Care Zealand University Hospital Køge Denmark
Department of Anaesthesia and Intensive Care Zealand University Hospital Roskilde Denmark
Department of Clinical Medicine University of Copenhagen Copenhagen Denmark
Department of Intensive Care Copenhagen University Hospital Rigshospitalet Copenhagen Denmark
Department of Intensive Care Gentofte Hospital Gentofte Denmark
Department of Intensive Care Guy's and St Thomas' Hospital London UK
Department of Intensive Care Hospital Vall d'Hebron Barcelona Spain
Department of Intensive Care Medicine Humanitas Research Hospital Milan Italy
Department of Intensive Care Medicine University Hospital Bern University of Bern Bern Switzerland
Department of Intensive Care Medicine University Hospital Brussels Jette Belgium
Faculty of Medicine and Pharmacy Vrije Universiteit Brussel Brussels Belgium
Medical Intensive Care Unit 1 Interni klinika Fakultni Nemocnice Plzen Czech Republic
Section of Biostatistics Department of Public Health University of Copenhagen Copenhagen Denmark
Citace poskytuje Crossref.org
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