Table 1

Characteristics of trials to date
Study title and abbreviation Design (all placebo-controlled) Population of ALI/ARDS A) Timing from ALI onset B) P/F ratio Number recruited Intervention Primary outcome Result (intervention vs control) Mortality (intervention vs control)
Neuromuscular Blockade in Early ARDS [5] Phase 2 RCT A) 48 hours B) <150 340 Cisatracuriumbesylate: 15 mg initially, then 37.5 mg per hour for 48 hours 90-day survival 31.6% vs 40.7% (P= 0.08) 28-day: 23.7% vs 33.3% (P= 0.05)
The β-Agonist Lung Injury Trial (BALTI) [6] Phase 1 RCT A) 48 hours B) <300 40 Intravenous (IV) salbutamol for seven days (15 μg kg-1 h-1) Extravascular lung water (EVLW) at Day 7 9.2 ± 6 vs 13.2 ±3 ml kg-1 (P= 0.04) 28-day: 58% vs 66% (P= 0.4)
Randomized, Placebo-Controlled Clinical Trial of an Aerosolized β2-Agonist for Treatment of Acute Lung Injury (ALTA) [7] Phase 2 RCT A) 48 hours B) < 300 282 Inhaled salbutamol (5 mg) every 4 hours for 10 days/24 hours after extubation Ventilator-free days (VFD) Stopped early 14.4 ± 0.9 vs 16.6 ± 0.9 (P= 0.087) Death before discharge: 24.3 ± 3.5 vs 18.5 ± 3.4 (P= 0.261)
Effect of Intravenous β-2 Agonist Treatment on Clinical Outcomes in Acute Respiratory Distress Syndrome (BALTI-2) [8] Phase 2 RCT A) 72 hours B) <200 326 IV salbutamol for seven days (15 μg kg-1 (ideal body weight) h-1) 28-day mortality Stopped early 34% vs 23% (P= 0.03)
Neutrophil Elastase Inhibition in Acute Lung Injury (STRIVE) [9] Phase 3 RCT A) 48 hours B) <300 492 Sivelestat infusion 1. 28-day mortality2. VFD Stopped early 1 26.6% vs 26% (P= 0.847)2. 11.4 ±10.27 vs 11.9 ± 10.1 (P= 0.536)
Efficacy and Safety of Corticosteroids for Persistent ARDS (LaSRS) [14] Phase 2 RCT A) 7 to 28 days B) P/F <200 180 Moderate-dose IV methylprednisolone, for up to 25 days 60-day mortality 29.2% vs 28.6% (P= 1.0)
Methylprednisolone Infusion in Early Severe ARDS [15] Phase 1 RCT A) 72 hours B) <300 91 Low-dose IV methylprednisolone, for up to 28 days Improvement in Lung Injury Score by Day 7 69.8% vs 35.7% (P= 0.002) Hospital survival 76.2% vs 57.1% (P= 0.07)
A Randomized Clinical Trial of Hydroxymethylglutaryl–Coenzyme A Reductase Inhibition for Acute Lung Injury (HARP) [19] Phase 2 RCT A) 48 hours B) <300 60 Simvastatin 80 mg daily, up to 14 days Reduction in EVLW indexed to actual body weight 13.7 vs 13.4 (P= 0.90) Improvements in secondary outcomes Hospital survival: 19 vs 19 (P= 1.0)
Nebulized Heparin is Associated with Fewer Days of Mechanical Ventilation in Critically Ill Patients: a Randomized Controlled Trial [21] Phase 2 RCT Patients expected to require ventilation for >48 hours, and within 24 hours of ventilation 50 Heparin 25,000 units every 4 to 6 hours, for up to 14 days Average daily P/F ratio 194.2 ± 62.8 vs 187 ± 38.6 mmHg (P= 0.6) Improvements in secondary outcomes 28-day: 20% vs 16% (P= 0.7)

Boyle et al.

Boyle et al. BMC Medicine 2013 11:166   doi:10.1186/1741-7015-11-166

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