Alveolar Recruitment for ARDS Trial: preliminary results

Abstract

Introduction The aim of the ongoing Alveolar Recruitment for ARDS Trial (ART) is to evaluate whether a maximum stepwise alveolar recruitment maneuver (MSARM) followed by ventilation at optimal PEEP may decrease 28-day mortality in patients with moderate to severe ARDS compared with ventilation with the ARDSNet strategy (NCT01374022). Here we report the results of a planned a priori preliminary analysis involving 100 patients to assess feasibility, physiologic variables and safety outcomes. Methods ART is an event-driven multicenter randomized controlled trial planned to last until 520 deaths within 28 days are observed. Patients assigned to the experimental group receive a MSARM achieving PEEP of 45 cmH2O and plateau pressure of 60 cmH2O plus PEEP titrated according to the static compliance of the respiratory system (ART strategy). The target tidal volume is 4 to 6 ml/kg predicted body weight (PBW) and plateau pressure 2O in both groups. Results We randomized 101 patients between November 2011 and October 2012 in 51 centers. Considering 124 active sites in July 2013 and the current recruitment rate, we will f nish enrollment by November 2014. MSARM was complete in 34/47 (72%) of patients allocated to the ART group. The main reason for MSARM interruption was hypotension (8/9 (90%)). Mean titrated PEEP in the ART group was 16.1 + 3.5 versus 12.9 + 3.4 cmH2O in ARDSNet (P 30 cmH2O 1 hour after randomization in the ART and ARDSNet groups (3/43 (7.0%) vs. 4/47 (8.5%), respectively; P = 1.00) and on subsequent days. PaO2/FiO2 was significant higher in the ART group (179.5 + 84.5 vs. 143.3 + 46.8, P = 0.01) and increased over time up to 7 days after randomization (272.3 + 136.5 vs. 192.6 + 72.3, P = 0.003). The ART strategy did not increase the risk of barotrauma (relative risk (RR) = 0.78, 95% CI = 0.19 to 3.30) in the first 7 days after randomization or the need to initiate or increase vasopressors or mean arterial pressure