• Journal of critical care · Dec 2023

    Randomized Controlled Trial

    Granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients presenting sepsis-induced immunosuppression: The GRID randomized controlled trial.

    • Charles-Hervé Vacheron, Alain Lepape, Fabienne Venet, Guillaume Monneret, Francois Gueyffier, Florent Boutitie, Helene Vallin, Carole Schwebel, Delphine Maucort-Boulch, Arnaud Friggeri, and GRID Study Group.
    • Département d'Anesthésie Réanimation, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France; CIRI-Centre International de Recherche en Infectiologie (Team PHE3ID), Univ Lyon, Université Claude Bernard Lyon 1, Inserm, U1111, CNRS, UMR5308, ENS Lyon, 46 allée d'Italie, Lyon 69007, France; Université Lyon 1. Electronic address: charles-herve.vacheron@chu-lyon.fr.
    • J Crit Care. 2023 Dec 1; 78: 154330154330.

    PurposeSeptic shock is associated in some patients with a profound immunosuppression. We hypothesized that GM-CSF would reduce the occurrence of ICU-acquired infections in immunosuppressed septic patients.MethodsRandomized double-blind trial conducted between 2015 and 2018. Adult patients, admitted to ICU, with severe sepsis or septic shock presenting with sepsis-induced immunosuppression defined by mHLA-DR < 8000 ABC (antibodies bound per cell) at day 3 were included. Patients were randomized to receive GM-CSF 125 μg/m2 or placebo for 5 days at a 1:1 ratio. The primary outcome was the difference in the number of patients presenting≥1 ICU-acquired infection at day 28 or ICU discharge.ResultsThe study was prematurely stopped because of insufficient recruitment. A total of 98 patients were included, 54 in the intervention group and 44 in the placebo group. The two groups were similar except for a higher body mass index and McCabe score in the intervention group. No significant difference was observed between groups regarding ICU-acquired infection (11% vs 11%, p = 1.000), 28-day mortality (24% vs 27%,p = 0.900), or the number or localization of the ICU infections.ConclusionGM-CSF had no effect on the prevention of ICU-acquired infection in sepsis immunosuppression, but any conclusion is limited by the early termination of the study leading to low number of included patients.Copyright © 2023 Elsevier Inc. All rights reserved.

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