Randomised controlled trials testing the use of steroids in low dose for septic shock
| Citation | Study group | Study type | Outcome | Key results | Comments |
|---|---|---|---|---|---|
| Annane et al (2002)2 | 300 adults with dopamine resistant septic shock divided according to the increase in cortisol in response to short corticotropin test (250 μg) as responders (>9 μg/dl) or non-responders (<9 μg/dl) | Randomised controlled trial (hydrocortisone 200 mg/day + fludrocortisone 50 μg/day v placebo, for 7 days) | 28 day survival Time to vasopressor withdraw | 28 day mortality of (steroids v placebo) 60/114 v 73/115 in the non-responders and 22/36 v 18/34 for responders–adjusted Odds ratios of 0.54 (0.31–0.97) and 0.97(0.32–2.97), respectively Time to withdraw vasopressor was (steroids v placebo) 7 v 10 days in non-responders (HR of 1.91 (1.29–2.84)) and 9 v 7 days in responders (p = 0.49) | Very specific population Large confidence intervals, upper limit close to 1 Do not report incidence of hyperglycaemia associated with steroids Number of patients needed to treat to save 1 additional life is 7 (4–49) |
| Bollaert et al (1998)4 | 41 adults with septic shock requiring catecholamine for more than 48 hours Response to corticotrophin stimulation test (increase >6 μg/dl) | Randomised controlled trial (300 mg/day hydrocortisone v placebo, for >5 days) | 7 day reversal of shock 28 day mortality | 7 day reversal of shock (15/22 v 4/19, p = 0.007) Mortality (7/22 v 12/19, p = 0.45) Similar improve (7 d, 28 m) in responder and non-responder | Discontinued early because primary end point was achieved Late inclusion of patients Large confidence intervals (7 day reversal of shock 17 to 77%) Other clinical interventions were not described |
| Yildiz et al (2002)3 | 40 adults with sepsis | Randomised controlled trial (prednisolone (7.5 mg/day, for 10 days) | 28 day mortality | 8/20 steroid and 12/20 placebo (p = 0.34) Higher difference in APACHE II>20 (not calculated) | Only 9 (22%) shocked Small sample No power calculation Trend for improve in survival, specially in the more severe group |