OBJECTIVES: To describe ARDS patients regarding survival, ventilation status, predisposing events, disease characteristics, length of hospital stay and duration of ventilation. METHODS: In a phase III clinical trial investigating treatment with Venticute (rSPC surfactant) compared to standard treatment in patients hospitalized for ARDS (NEJM 351, 884-892, 2004), patients were followed up for up to one year after randomization. This analysis is focused on the initial hospitalization and describes the pooled results from both treatment groups. Data were collected for 197 patients by means of a specific questionnaire covering hospital mortality, length of stay, resource use and the TISS 28, a tool developed to assess workload of hospital staff for intensive care patients. Economic aspects were assessed using published average daily costs as approximation of item costs. RESULTS: A total of 62% of ARDS patients were male, median age of 55 years, and most patients with socioeconomic data were either working or in retirement. The main predisposing events for ARDS were sepsis (51%), pneumonia (35%) and trauma or surgery (28%). During the initial hospitalization 70 patients (36%) died. Overall length of hospital stay was 31±41 (mean±SD) days, with most days spent in the Intensive Care Unit (ICU; 20±21 days) and General Ward (8± 22 days). On average patients were artificially ventilated for 16±14 days and intubated for 16±15 days. As assessed by the TISS 28, the average daily TISS score was 33±10, which corresponds to a nursing time of 5.9 hours per day, and mainly related to basic activities (12±3), ventilatory support (6±2) and cardio-vascular support (10±5). Average overall hospital costs amount to 38,263 USD per patient. CONCLUSIONS: ARDS is a severe condition with a high mortality during inpatient treatment. Patients are treated mainly in the ICU requiring intensive artificial ventilation and high nursing workload, thereby resulting in high treatment cost.