Inhalation of nitric oxide in acute lung injury: results of a European multicentre study

Objective: To determine whether inhalation of nitric oxide (INO) can increa se the frequency of reversal of acute lung injury (ALI) in nitric oxide (NO ) responders. Design: Prospective, open, randomised, multicentre, parallel group phase II I trial. Setting: General ICUs in 43 university and regional hospitals in Europe. Patients: Two hundred and sixty-eight adult patients with early ALI. Interventions: NO responders were patients whose PaO2 increased by more tha n 20 % when receiving 0, 2, 10 and 40 ppm of INO for 10 min within 96 h of study entry. Responders were randomly allocated to conventional treatment w ith or without INO. INO, 1-40 ppm, was given at the lowest effective dose f or up to 30 days or until an end point was reached. The primary end point w as reversal of ALI. Clinical outcome parameters and safety were assessed in all patients. Results: Two hundred and sixty eight patients were recruited, of which 180 were randomised NO responders. Frequency of reversal of ALI was no differen t in INO patients (61 %) and controls (54 %; p > 0.2), Development of sever e respiratory failure was lower in the INO (2.2 %) than controls (10.3 %; p < 0.05). The mortality at 30 days was 44 % for INO patients, 40 % for cont rol patients (p > 0.2 vs INO) and 45 % in non-responders. Conclusions: Improvement of oxygenation by INO did not increase the frequen cy of reversal of ALI. Use of inhaled NO in early ALI did not alter mortali ty although it did reduce the frequency of severe respiratory failure in pa tients developing severe hypoxaemia.