Table 4.

Summary of Clinical Studies of Glucocorticoids in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS)

Intervention	Author & Year	Study Design	Study Population & Number of Patients	Results
Methylprednisolone (30 mg/kg IV every 6 h × 48 h) or placebo	Weigelt et al 1985 [108]	Prospective, randomized, placebo- controlled, double-blind study, phase III	Acutely ill, mechanically ventilated patients with 350 PaO2/FiO2 ≤ (considered high risk for ARDS), N = 81	Increased incidence of ARDS in steroid group (64% vs 33%; P = .008). Increase in mortality rate in the steroid group 46% vs 31% was not statistically significant (P = .177)a
Methylprednisolone 30 mg/kg IV or dexamethasone 6 mg/kg (×1 or 2 doses) or nothing	Sprung et al 1984 [109]	Prospective, randomized study, phase III	Patients with septic shock, N = 59	No difference in incidence of ARDS (23% vs 13% vs 12.5%, respectively.). No difference in overall mortality rate and reversal of septic shocka
Methylprednisolone (30 mg/kg IV every 6 h × 24 h) or placebo	Bone et al 1987 [110]	Prospective, randomized, placebo- controlled, double-blind study, phase III	Patients with sepsis, N = 304	Trend toward increased incidence of ARDS in steroid group (32% vs 25%). Increased mortality in steroid group (61% vs 22%, P = .004)
Methylprednisolone (30 mg/kg IV every 6 h × 24 h) or placebo	Luce et al 1988 [111]	Prospective, randomized, placebo- controlled, double-blind study, phase III	Patients with septic shock, N = 75	No difference in incidence of ARDS (34% vs 37%, P not significant). No difference in overall mortality rate: 22/38 in steroid group vs 20/37 in placebo group
Methylprednisolone (30 mg/kg IV every 6 h × 24 h) or placebo	Bernard et al 1987 [112]	Prospective, randomized, placebo- controlled, double-blind study, phase III	Patients with ARDS, N = 99	No difference in mortality rate: 60% in the steroid group vs 63% in placebo, P = .74a
Methylprednisolone IV 125 mg every 6 h (taper on improvement of PaO2/FiO2), course of 21 d	Asbaugh & Maier 1985 [113]	Case series	Patients with persistent ARDS and idiopathic pulmonary fibrosis on open lung biopsy, N = 10	Mortality rate 20% (2/10 patients); mostly young patients with trauma (mean age 37)
Methylprednisolone IV 125–250 mg × 72–96 h then taper (course >21 d)	Hooper & Kearl 1990 [114], 1996 [115]	Case series	Patients with established ARDS (>72 h), positive 67Ga scan at 48 h, N = 10, N = 26 (including 10 patients above)	Mortality rate 19% (5/26 patients)
Methylprednisolone IV, initial bolus 200 mg, then 2–3 mg/kg/d, taper after extubation or after 14 d	Meduri et al 1991 [116], 1994 [117]	Case series	Patients with ARDS with progressive respiratory failure with worsening LIS and no infection, N = 8, N = 25 (including previous 8)	Overall mortality rate 24% (6/25 patients)
Methylprednisolone IV 2 mg/kg/d × 32 d	Meduri et al 1998 [118]	Prospective, randomized, placebo- controlled, double-blind study, phase III	Patients with severe ARDS who failed to improve LIS by day 7. Patients with infection excluded, N = 24	Overall mortality rate 12% (2/16) in steroid group vs placebo 63% (5/9); P = .03. Infection rate similar in both groups
Methylprednisolone IV, initial loading dose 2 mg/kg followed by 0.5 mg/kg every 6 h × 14 d and 0.5 mg/kg every 12 h × 7 d	ARDS network, unpublished data	Prospective, randomized, multiple-center, placebo- controlled study, phase III	Patients with persistent ARDS (>7 d) and no evidence of infection, N = 180	No difference in mortality.

IV – intravenously; LIS – lung injury score.

^aHigher incidence of infections in the steroid group.

^bNo increase in infectious complications, but increased incidence of myopathy in the steroid group (9 vs 0 for placebo) and higher incidence of reintubations.