6/28/23, 12:10 AM CLASSIC Pathway Feedback Search Clinical Topics Home Studies CLASSIC CLASSIC Disease Sepsis and septic shock Trial question What is the role of intravenous fluid restriction in ICU patients with septic shock? Study design Multi-center Open label RCT Population Characteristics of study participants 41.0% female N = 1545 59.0% male 1545 patients (627 female, 904 male) Inclusion criteria: patients with septic shock in the ICU who received at least 1 L of intravenous fluid Key exclusion criteria: septic shock for > 12 hours; life-threatening bleeding; acute burn injury involving > 10% of BSA; pregnancy Interventions N=764 restrictive fluid (no intravenous fluids administration unless extenuating circumstances occur) N=781 standard fluid (no upper limit for the use of intravenous fluids) Primary outcome Death at day 90 42.3 % 42.3 42.1 31 7 % https://web.pathway.md/studies/recfN08vkDI5Wkeas 1/2 6/28/23, 12:10 AM 31.7 % CLASSIC Pathway 21.1 % 10.6 % No significant difference 0.0 % Restrictive fluid Standard fluid No significant difference in death at day 90 (42.3% vs. 42.1%; AD 0.1%, 95% CI -4.7 to 4.9) Secondary outcomes No significant difference in serious adverse reaction (4.1% vs. 4.1%; ARD -0.1, 99% CI -2.8 to 2.6) No significant difference in days alive and out of the hospital (21 days vs. 33 days; ARD -12, 95% CI -30 to 6) Conclusion In patients with septic shock in the ICU who received at least 1 L of intravenous fluid, restrictive fluid was not superior to standard fluid with respect to death at day 90. Reference Tine S Meyhoff, Peter B Hjortrup, J rn Wetterslev et al. Restriction of Intravenous Fluid in ICU Patients with Septic Shock. N Engl J Med. 2022 Jun 30;386(26):2459-2470. Open reference URL https://web.pathway.md/studies/recfN08vkDI5Wkeas 2/2