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

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 versus (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 one 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.