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It has been suggested that fibrosis present during the fibroproliferative phase of acute respiratory distress syndrome (ARDS) can be treated by corticosteroids. However, neither clinical nor microbiologic criteria permit differentiation of this fibroproliferative phase from a nosocomial pneumonia. The aim of this observational case series was to evaluate the safety and utility of open-lung biopsy (OLB) performed in patients receiving ventilatory support who had persistent ARDS despite negative bacterial cultures.During a 4-yr period, 37 OLBs were performed in 36 of 197 patients receiving ventilatory support who had ARDS. The severity of ARDS was assessed by a lung injury score of 3.1 +/- 0.4 (mean +/- SD) and a median ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of 118 mmHg. Histologic examination; bacterial, fungal, and acid-fast staining; and cultures of the tissue sample were performed.Fibrosis was present in only 41% of the lung specimens obtained by OLB. Only six patients received corticosteroids (17%). In 9 of the 15 patients with fibrosis, cytomegalovirus pneumonia precluded the use of corticosteroids. Histologic cytomegalovirus pneumonia was diagnosed in 18 cases. Histologic bacterial or mycobacterial pneumonia was diagnosed in five cases. No significant change in arterial blood gases was noted as linked to the biopsy procedure except an increase of the PaO2 /FI O2 ratio. One pneumothorax was diagnosed on a chest roentgenogram 12 h after OLB. Only one patient required blood transfusion during the 48-h period after OLB (for an hemothorax). Five patients had moderate air leaks from operative chest tubes for 2–10 days.Open lung biopsy appeared to be a useful and acceptably safe diagnostic technique in patients with ARDS. It permitted the diagnosis of unexpected cytomegalovirus pneumonia.