Granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients presenting sepsis-induced immunosuppression: The GRID randomized controlled trial.
J Crit Care
; 78: 154330, 2023 12.
Article
in En
| MEDLINE
| ID: mdl-37267804
ABSTRACT
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 µg/m2 or placebo for 5 days at a 11 ratio. The primary outcome was the difference in the number of patients presenting≥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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Shock, Septic
/
Sepsis
Type of study:
Clinical_trials
Limits:
Adult
/
Humans
Language:
En
Journal:
J Crit Care
Journal subject:
TERAPIA INTENSIVA
Year:
2023
Document type:
Article