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

被引:13
作者
Vacheron, Charles-Herve [1 ,12 ,14 ]
Lepape, Alain [1 ,2 ]
Venet, Fabienne [3 ]
Monneret, Guillaume [4 ]
Gueyffier, Francois [5 ,13 ]
Boutitie, Florent [6 ]
Vallin, Helene [7 ]
Schwebel, Carole [8 ]
Maucort-Boulch, Delphine [9 ]
Friggeri, Arnaud [10 ,11 ]
机构
[1] Hosp Civils Lyon, Ctr Hospitalier Lyon Sud, Dept Anesthesie Reanimat, Lyon, France
[2] Hop Henry Gabrielle, REA REZO Infect & Antibioresistance Reanimat, Villa Alice, 20 Route Vourles, F-69230 St Genis Laval, France
[3] Hop Edouard Herriot, Immunol Lab, Hosp Civils Lyon, 5 Pl Arsonval, F-69437 Lyon 03, France
[4] Hosp Civils Lyon, Hop E Herriot, Lab Immunol, Lyon, France
[5] Pole St Publ, Hosp Civils Lyon, F-69003 Lyon, France
[6] Hosp Civils Lyon, Serv Biostat, F-69003 Lyon, France
[7] Hosp Civiles Lyon, 3 Quai Celestins,FranceUniv Lyon 1 8 Av Rockefelle, Lyon, France
[8] CHU Grenoble Alpes, Serv Medecine Intens Reanimat, F-38700 La Tronche, France
[9] Pole St Publ, Serv Biostat & Bioinformat, Hosp Civils Lyon, F-69003 Lyon, France
[10] Ctr Hosp Lyon Sud Hosp Civils Lyon, Dept Anesthesie Reanimat, Pierre Benite, France
[11] Univ Claude Bernard Lyon 1, Univ Lyon, CNRS, Inserm,UMR5308,U1111,ENS Lyon,Team PHE3ID,CIRI Ctr, 46 Allee Italie, F-69007 Lyon, France
[12] Univ Lyon 1, Villeurbanne, France
[13] Univ Lyon 1, UMR 5558, Lab Biometrie & Biol Evolut, F-69100 Villeurbanne, France
[14] Ctr Hospitalier Lyon Sud, Serv Anesthesie Reanimat, 165 Chemin Grand Revoyet, F-69495 Pierre Benite, France
关键词
Sepsis; Immunosuppression; GM-CSF; HLA-DR; HLA-DR EXPRESSION; MONOCYTE; DEFINITIONS; INFECTION;
D O I
10.1016/j.jcrc.2023.154330
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
Purpose: Septic 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.Methods: Randomized 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 & mu;g/m2 or placebo for 5 days at a 1:1 ratio. The primary outcome was the difference in the number of patients presenting & GE;1 ICU-acquired infection at day 28 or ICU discharge.Results: The 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.Conclusion: GM-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.
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页数:6
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