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

Copenhagen Trial Unit Centre for Clinical Intervention Research Copenhagen University Hospital Rigshospitalet Copenhagen Denmark

Department of Anaesthesia and Intensive Care Aalborg University Hospital Aalborg Denmark

Department of Anaesthesia and Intensive Care Copenhagen University Hospital Bispebjerg Copenhagen Denmark

Department of Anaesthesia and Intensive Care Lillebaelt Hospital Kolding Denmark

Department of Anaesthesia and Intensive Care Nordsjaellands Hospital University Hospital of Copenhagen Hillerød 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 Maastricht University Medical Center University Maastricht Maastrict The Netherlands

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

Department of Perioperative Medicine and Intensive Care Karolinska University Hospital Huddinge Stockholm Sweden

Division of Emergencies and Critical Care Department of Anaesthesiology Oslo University Hospital Rikshospitalet Oslo Norway

Division of Intensive Care Medicine Department of Anaesthesiology Intensive Care and Pain Medicine Helsinki University Hospital University of Helsinki Helsinki Finland

Faculty of Medicine and Pharmacy Vrije Universiteit Brussel Brussels Belgium

Medical Intensive Care Unit 1 Interni klinika Fakultni Nemocnice Plzen Czech Republic

Section of Anaesthesia and Intensive Care Department of Clinical Science and Education Södersjukhuset Karolinska Institutet Stockholm Sweden

Section of Biostatistics Department of Public Health University of Copenhagen Copenhagen Denmark

Intensive Care Med. 2023 Jul;49(7):820-830. doi: 10.1007/s00134-023-07114-8. PubMed

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Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock

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NCT03668236