Table 1 Characteristics of included trials
From: Glucocorticosteroids for sepsis: systematic review with meta-analysis and trial sequential analysis
Trial | Number of patients | Inclusion criteria | Treatment | Mortality data |
|---|---|---|---|---|
High dose steroids (>500 mg hydrocortisone or equivalent dose) in experimental intervention group | ||||
Bernard [35] | 99 | Sepsis | MP 30 mg/kg every 6 h for a total of 4 doses | 45 days |
Bone [41] | 382 | Severe sepsis | MP bolus 30 mg/kg repeated every 6 h up to a total of 4 doses | 14 days and ICU |
De Gans [36] | 301 | Sepsis | D 10 mg every 6 h for 4 days | 8 weeks |
Hoffman [37] | 38 | Sepsis | D 3 mg/kg, followed by 1 mg/kg every 6 h for 8 times | 16 months |
Hughes [28] | 57 | Septic shock | Group A (n = 14): bolus N 10 μg/kg and a single dose of 30 mg/kg MP and 30 min later: a second dose of 100 μg/kg N Group B: (n = 15) single bolus of 30 mg/kg MP Group I (n = 7): 30 μg/kg bolus of N, followed by 30 μg/kg/h for 1 h plus a single dose of 30 mg/kg MP Group II (n = 7), bolus 30 μg/kg N, followed by 30 μg/kg/h for 1 h without MP Group III (n = 7): MP, 30 mg/kg | Not reported |
Klastersky [29] | 85 | Sepsis | B 0.5 mg/kg every 12 h, during 3 consecutive days | 30 days |
Luce [42] | 87 | Septic shock | MP 30 mg/kg per dose every 6 h, four times MP diluted in 50 ml of 5 % dextrose in water | Hospital |
Marik [38] | 30 | Sepsis | Once HC 10 mg/kg iv 30 min prior to starting antibiotic therapy | Not specified |
Scarborough [30] | 465 | Sepsis | D 16 mg in 4 ml of sterile water intravenously for 4 days | 10 days, 40 days, 6 months |
Schumer [43] | 172 | Septic shock | Single bolus infusion of either 3 mg/kg D in 100 ml IS or 30 mg/kg of MP in 100 ml IS. If ‘necessary’ repeated once after 4 h | Not specified |
Sprung [44] | 59 | Septic shock | Group 1 (n = 21): MP 30 mg/kg Group 2 (n = 22): D 6 mg/kg Dose was repeated once in both groups after 4 h if shock persisted | 7 days, 14 days and 20 days |
Thwaites [20] | 545 | Sepsis | D week 1, 0.4 mg/kg/day; week 2, 0.3 mg/kg/day; week 3, 0.2 mg/kg/day; week 4, 0.1 mg/kg/day; week 5, fixed dose 4 mg/day, decreased by 1 mg each week in following weeksa | 9 months |
VASSC [45] | 223 | Sepsis | MP 30 mg/kg bolus followed by 5 mg/kg/h for 9 h Maximal dose 10 g | 14 days |
Wan [31] | 81 | SIRS | D iv 1 mg/kg 3 times/day for 3 days | 30 days |
Low dose steroids (≤500 mg hydrocortisone or equivalent dose) in experimental intervention group | ||||
Annane [46] | 300 | Septic shock | HC 50 mg every 6 h and FC 50 µg every 24 h Treatment duration 6 days | 1 year |
Arabi [47] | 75 | Septic shock and cirrhosis | 50 mg HC every 6 h. After shock resolution, defined as a MAP > 65 mm Hg without vasopressors for 24 h: dose reduction by 10 mg every 2 days until discontinuation | 28 days, ICU and hospital |
Bollaert [48] | 41 | Septic shock | HC 75 mg every 6 h for 5 or more days. In case of shock reversal after 5 days: for 3 days 150 mg HC, then 75 mg for the next 3 days. Treatment was stopped after 5 days in the absence of shock reversal | 28 days |
Briegel [49] | 40 | Septic shock | HC bolus of 100 mg, followed by a continuous infusion of 0.18 mg/kg/h. After shock reversal dose reduction to 0.08 mg/kg/h. Dose was kept constant for 6 days. HC was tapered in steps of 24 mg/day after successful treatment of infection or serum [sodium] >155 mmol/l | 30 days, 90 days, 1 year and ICU |
Chawla [50] | 44 | Septic shock | HC 100 mg every 8 h for 72 h, followed by tapering over 4 days | Not reported |
Cicarelli [32] | 29 | SIRS with or without sepsis | D 0.2 mg/kg (in a single dose) | 7 days |
Cicarelli [51] | 29 | Septic shock | D 0.2 mg/kg given three times at intervals of 36 h | 7 and 28 days |
Confalonieri [33] | 46 | Sepsis | HC bolus 200 mg, followed by an infusion rate of 10 mg/h for 7 days | 7, 28, 60 days and hospital |
Gordon [52] | 61 | Septic shock | HC 50 mg every 6 h for the first 5 days, 50 mg every 12 h for the next 3 days, 50 mg every 24 h for the last 3 days. HC was weaned quicker if shock had resolved | 28 days, ICU and hospital |
Hu [53] | 77 | Septic shock | HC 50 mg every 6 h for the first 7 days, 50 mg every 8 h for the next 3 days, 50 mg every 12 h for the next 2 days 50 mg every 24 h for the next 2 days | 14 days |
Kaufmann [54] | 30 | Septic shock | HC bolus of 100 mg followed by a continuous infusion of 10 mg/h for 24 h | Not reported |
Mirea [55] | 171 | Septic shock | Group A: bolus 200 mg HC every 24 h during 4 days Group B: continuous HC 200 mg/day during 4 days | Not reported |
Meduri [56] | 80 | Severe sepsis | HC infusion (10 mg/h) for 7 days | ICU and hospital |
Nafae [39] | 80 | Sepsis | HC 200 mg loading bolus dose followed by a continuous infusion of 240 mg/24 h for 7 days | 7 days |
Oppert [57] | 48 | Septic shock | HC (500 mg/50 ml) bolus 50 mg, followed by continuous infusion of 0.18 mg/kg/h. 1 h after cessation of vasopressor support: 0.06 mg/kg/h for 24 h, followed by a reduction of 0.02 mg/kg/h every day | 28 days |
Rinaldi [58] | 40 | Severe sepsis | Standard therapy and HC 300 mg/day diluted in 50 ml of IS for 6 days via continuous intravenous infusion. After the study period HC therapy was tapered | Hospital |
Ruolan [59] | 60 | Sepsis | Chinese herb group: 100 ml Sini decoctionb every 24 h for 7 days HC group (GOI): 200 mg HC every 24 h for 7 days | 28 days |
Snijders [40] | 213 | Sepsis | P 40 mg once daily for a total of 7 days | 30 days |
Sprung [60] | 499 | Septic shock | HC 50 mg iv bolus every 6 h for 5 days, then tapered to 50 mg iv every 12 h for days 6–8, 50 mg every 24 h for days 9–11, and then stopped | Mortality rate at 28 days in patients who did and did not have RC Overall 28 days, ICU, hospital, 1 year |
Yildiz [61] | 40 | Sepsis | P iv at 06.00 (5 mg) and 18.00 (2.5 mg) for 10 days | 28 days |
Yildiz [62] | 55 | Sepsis | P iv 3 times a day at 06.00 (10 mg), 14.00 (5 mg), and 22.00 (5 mg) for 10 days | 28 days |