Safety of granulocyte colony-stimulating factor (filgrastim) in intubated patients in the intensive care unit: Interim analysis of a prospective, placebo-controlled, double-blind study

Objective: To investigate the safety of the granulocyte colony-stimulating factor filgrastim in the prevention of nosocomial infections in intubated p atients in the intensive care unit (ICU), with special emphasis on the poss ible deleterious effect on acute respiratory distress syndrome (ARDS) and t he development of multiple organ dysfunction (MOD). Design: Predetermined, interim analysis of a prospective, randomized, place bo-controlled, double-blind trial. Setting: University hospital medical-surgical ICU. Patients: A total of 59 consecutive ICU patients, aged >18 yrs, admitted to the ICU no more than 12 hrs before the study, intubated because of ventila tory insufficiency no more than 48 hrs before the study, expected to stay i n the ICU for >48 hrs, and had informed consent from the next relative. Interventions: Patients were randomized to receive either placebo or 300 mu g of filgrastim subcutaneously once daily for 7 days. Measurements and Main Results:No significant differences were found in the number of patients developing ARDS (2 of 20 in the placebo group vs. 0 of 2 2 in the filgrastim group), disseminated intravascular coagulation (3 of 27 vs. 3 of 29), acute renal failure (1 of 27 vs. 1 of 23), or change in MOD. Data analysis showed nosocomial infections in 11 of 29 patients in the pla cebo group and in 7 of 30 patients in the filgrastim group (p = .266). The median (range) length of ICU stay was 8 (1-34) days in the placebo group an d 6 days (1-28) in the filgrastim group. The day 28 mortality rate was 17% (5 of 29) in the placebo group and 13% (4 of 30) in the filgrastim group. N o drug-related adverse events occurred. Conclusion: Filgrastim is safe in intubated ICU patients, with no excess ri sk for development of ARDS or MOD.