Table 1.
Randomized controlled trials of CS in adult patients with ARDS or sepsis.
| Author (Year) | Diagnosis | Total No. of Patients (CS/Placebo) |
Treatment/Dose | Duration of Therapy (Days) | Outcomes in CS Groups |
|---|---|---|---|---|---|
| Bernard et al. (1987) [82] | Early ARDS | 99 (50 CS/49 placebo) |
Methylprednisolone (30 mg/kg 6-hourly) |
1 | No differences in mortality, infectious complications or ventilatory characteristics 5 days after entry |
| Meduri et al. (1998) [83] | Severe persistent ARDS | 24 (16 CS/8 placebo) |
Methylprednisolone (2 mg/kg loading dose, then 2 mg/kg/day for days 1–14, 1 mg/kg/day for days 15–21, 0.5 mg/kg/day for days 22–28, 0.25 mg/kg/day for days 29–30, and 0.125 mg/kg/day for days 31–32) |
14 | Improvements in LIS and PaO2/FiO2 Reduced ICU and hospital mortality No increase in infection complications |
| Confalonieri et al. (2005) [84] | Severe community-acquired pneumonia | 46 (23 CS/23 placebo) |
Hydrocortisone (bolus 200 mg, then infusion 10 mg/hour) |
7 | Improvement in PaO2/FiO2 and chest X-ray score Reduction in CRP levels, MODS score, and delayed septic shock Reduction in length of hospital stay and mortality |
| Steinberg et al. (2006) [85] | Persistent ARDS | 180 (89 CS/91 placebo) |
Methylprednisolone (2 mg/kg loading dose, then 0.5 mg/kg 6-hourly for 14 days, 0.5 mg/kg 12-hourly for 7 days) |
14 | Starting CS therapy later than 2 weeks after the onset of ARDS associated with increased mortality |
| Annane et al. (2006) [86] | Septic patients with ARDS | 177 (85 CS, including 23 responders/92 placebo, including 25 responders) |
Hydrocortisone (50 mg 6-hourly) and 9-α- fludrocortisone (50 mg once a day) |
7 | In nonresponders to short corticotrophin test: decreased mortality and more ventilator days off, no difference in responders |
| Meduri et al. (2007) [87] | Early severe ARDS | 91 (63 CS/28 placebo) |
Methylprednisolone (1 mg/kg loading dose, then 1 mg/kg/day for days 1–14, 0.5 mg/kg/day for days 15–21, 0.25 mg/kg/day for days 22–25, 0.125 mg/kg/day for days 26–28) |
Shorter duration of mechanical ventilation Reduced ICU stay and ICU mortality No increase in infectious complications |
|
| Meijvis et al. (2011) [88] | Community-acquired pneumonia | 304 (151 CS/153 placebo) |
Dexamethasone (5 mg once a day) | 4 | Shorter length of stay No differences in hospital mortality or severe adverse events More common hyperglycaemia |
| Tongyoo et al. (2016) [89] | Severe sepsis or septic shock | 197 (98 CS, 99 placebo) |
Hydrocortisone (50 mg 6-hourly) | 7 | Improvement in PaO2/FiO2 and LIS No survival benefit More frequent hyperglycaemia |
| Keh et al. (2016) [90] | Severe sepsis | 380 190 CS/190 placebo) |
Hydrocortisone (200 mg continuous infusion for 5 days, then dose tapering until day 11) |
5 | No reduction of risk of septic shockNo differences in mortality in ICU or in the hospital Higher occurrence of secondary infections, muscle weakness, and hyperglycemia |
| Annane et al. (2018) [91] | Septic shock | 1241 (614 CS/627 placebo) |
Hydrocortisone (50 mg 6-hourly) and 9-α- fludrocortisone (50 mg once a day) |
7 | Lower 90-day mortality More vasopressor-free days and organ-failure-free days to day 28 No difference in ventilator-free days and rate of serious adverse events More common hyperglycemia |
| Venkatesh et al. (2018) [92] | Septic shock | 3658 (1832 CS/1826 placebo) |
Hydrocortisone (200 mg per day) |
7 | No improvement in 90-day mortality Faster resolution of shock Fewer blood transfusions Shorter duration of initial mechanical ventilation No difference in ventilation-free days |