Table 2.

RCT evaluating the use of glucocorticoids in acute respiratory distress syndrome

Study, year, journal	Study design	Drug and dose	Sample size	Inclusion criteria	Primary outcome	Results (primary outcome)	Secondary outcome results	Adverse effects
Villar et al, 2020, Lancet Respir Med36	RCT 1:1	DXM (20 mg gd days 1–5, then 10 mg gd days 6–10) vs. no steroid	277	Adult IMV ARDS	Ventilator-free days at day 28	Achieved. 12.3 (9.9) d in DXM group vs. 7.5 (9.0) d in no steroid group. Mean difference 4.8 (2.57–7.03), p <0.0001	Significant reduction in all-cause mortality at day 60, ICU mortality, hospital mortality, duration of MV in ICU survivors, duration of MV in survivors at day 60 in the DXM group.	No significant differences
Tongyoo et al, 2016, Crlt Care37	Double-blind, placebo-controlled, RCT 1:1	HCS (50 mg g6h for 7 d)vs. placebo	206	Adult Severe sepsis or septic shock ARDS	Mortality at day 28	Not achieved. 22 (22.5) in HCS group vs. 27 (27.3) in placebo group. RR 0.82 (0.50–1.34), p = 0.51	No significant differences in mortality at 60 d, duration of MV at day 28, MV-free days at day 28, duration of vasopressor treatment, RRT, duration of RRT, need for organ support, organ support-free days at day 28.	Hyperglycemia
Medurl et al, 2007, Chest38	Double-blind, placebo-controlled, RCT 2:1	MP (1 mg/kg load, then 1 mg/kg gd for 14 d, then 0.5 mg/kg gd for 7 d, then 0.25 mg/kg gd for 4 d, then 0.1 25 mg/kg gd for 3 d) vs. placebo	91	Adult IMV ARDS	Improvement in LIS at day 7	Achieved. 44 (69.8) in MP group vs. 10 (35.7) in placebo group. RR 1.96 (1.16–3.30), p = 0.002	Significant reduction in need for breathing assistance, PEEP, MV-free days, MODS score, CRP, plasma cortisol, and increase in P/F in ventilated patients in the MP group at day 7. No significant differences in new infections, VAP, and mortality at day 7.	Increased incidence of pneumonia in the placebo group
Steinberg et al 2006, N Engl J Med39	Double-blind, placebo-controlled, RCT 1:1	MP (2 mg/kg load, then 0.5 mg/kg g6h for 14 d, then 0.5 mg/kg q 12h for 7 d, then tapering) vs. placebo	180	IMV 7–28 d after diagnosis of ARDS MV Persistent bilateral infiltrates P/F <200	Mortality at day 60	Not achieved. 28.6 (20.8–38.6) in MP vs. 29.2 (20.8–39.4) in placebo group, p = 1.0	Significant reduction in ventilator-free days, and cardiovascular failure free days at day 28 in the MP group. No significant differences in coagulation abnormalities, hepatic failure, renal failure, and ICU free days at day 28.	Increased incidence of pneumonia and shock events in the placebo group
Meduri et al, 1998, JAMA40	Double-blind, placebo-controlled, RCT 2:1	MP (2 mg/kg bolus, then 2 mg/kg for 14 d, then 1 mg/kg for 7 d, then 0.5 mg/kg for 7 d, then 0.25 mg/kg for 2 d, then 0.1 25 mg/kg for 2 d) vs. no steroid	24	Adult ARDS 7 d of MV	Improvement in lung function and mortality	Achieved for P/F at day 10. 26219 in MP group vs. 14835 in no steroid group, p <0.001 Achieved for LIS. 1.7 (0.1) in MP group vs. 3.0 (0.2) in no steroid group, p <0.001	Significant reduction in pulmonary artery pressure, successful extubation, MODS score, and duration of MV in the MP group. No significant differences in new infections, new VAP, and survivors.	No significant differences

Abbreviations: ARDS, acute respiratory distress syndrome; CRP C-reactive protein; DXM, dexamethasone; HCS, hydrocortisone; ICU, intensive care unit; IMV: invasive mechanical ventilation; iv, intravenous; LIS, lung injury score; MODS, multiple organ dysfunction syndrome; MP, méthylprednisolone; MV, mechanical ventilation; NIMV, noninvasive mechanical ventilation; P/F, arterial oxygen partial pressure out of FiO₂; PEEP, positive end expiratory pressure; PDN, prednisolone; q6h/q12h, every 6/12 h administration; qd, once a day; RCT, randomized controlled trial; RR, risk ratio; RRT, renal replacement therapy; SpO₂, peripheral oxygen saturation; VAP, ventilator-acquired pneumonia; vs, versus.