Bovine surfactant in the treatment of severe ARDS (paO2/FiO2 ratio < 100) in children - A multicenter randomized study

Severe ARDS in children is still associated with a high mortality (> 55% in the german pediatric ARDS registry). Many new treatment options as high frequency ventilation (HFO), nitric oxide (NO), ECMO and surfactant have been introduced, however, not been compared in randomized studies. ARDS is always associated with secondary surfactant deficiency. Patients and Methods: Children with ARDS (def.by Murray Score, consensucs conf.) age 44 pc weeks to 14 years ventilated between 12 and 120 hrs. were randomized as soon as the paO2/FiO ₂ ratio fell < 100. Patients with chronic lung disease were excluded. Basic therapy had to be performed in accordance with strictly enforced guidelines for hemodynamic (catecholamines, fluids) and ventilatory management (time cycled, PIP < 35 cm H₂O).The treatment group got 100 mg/kg bovine surfactant (Alveofact®,Boehringer, Ingelheim, Germany) to a maximum of 2 doses. Primary outcome criteria was the paO2/FiO2 ratio after 48 hrs., secondary outcome criteria: survival and survival without rescue therapy (NO, HFO, surfactant, ECMO)at 30 days. Steroids and prostaglandines were not permitted. Results:Patients of the treatment group (n=21) and surfactant group (n=17) did not have different Murray of PRISM III scores, nor was the number of immunosuppressed patients different. PaO2/FiO2 ratio increased in the treatment group by 93 (SD±90) and in the controls by 45 (±63), p<0.05. There was no difference and no increase of paO2/FiO2 ratio in patients who were enrolled with a initial paO2/FiO2 <60. The mortality in the treatment group was 45% at 30 days, 60% in controls (p<0.05). 15% of controls compared to 50% in the treatment group survived without rescue therapy at 30 days (p<0.05). Conclusions: Treatment with bovine surfactant in children with severe ARDS improves oxygenation, survival, and survival without rescue therapy. This effect was much more pronounced in patients with an initial paO2/FiO2 ratio > 60. However, even patients under standardized conventional hemodynamic and respiratory management im-prove over 48 hrs.