Table 2 Final study cohort
Study | Year published | Year completed | Trial origin | Trial | Reported as Paper#/abstract | Design | Allocation concealment | Effect and sample size calculation | Early stopping | Sepsis/shock description | Predominant patient type | Primary outcome |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cooperative Study Group [32] | 1963 | NA | USA | Multicenter | Paper | Double-blind | Yes | No | No | 'Life threatening infections' | Medical | Hospital mortality |
Klastersky and colleagues [41] | 1971 | 1970 | Belgium | Singlecenter | Paper | Double-blind | Yes | No | No | 'Life threatening infections' | Cancer | 30-day mortality |
Schumer [31] | 1976 | 1975 | USA | Singlecenter | Paper | Double-blind | NA | No | No | Septic history, falling blood pressure and positive blood cultures | Surgical | 28-day mortality |
Sprung and colleagues [43] | 1984 | 1982 | USA | Two-centers | Paper | Open-label | Yes | No | No | SBP < 90 mmHg, decreased organ perfusion hypotension despite fluid infusion, and bacteraemia or identified infection source | Medical | Hospital mortality |
Bone and colleagues [38] | 1987 | 1985 | USA | Multicenter | Paper | Double-blind | Yes | No | No | Evidence of infection, fever/hypothermia tachypnoea, inadequate organ perfusion/dysfunction, SBP < 90 mmHg/decrease 40 mmHg | Mixed | SS development ≤14 days post admission; reversal SS ≤14 days; death ≤14 days |
Luce and colleagues [46] | 1988 | 1986 | USA | Singlecenter | Paper | Double-blind | Yes | Yes | Yes | Fever/hypothermia, SBP < 90 mmHg, blood culture or body-fluid positive | Mixed | ARDS development, Hospital mortality |
Bollaert and colleagues [37] | 1998 | NA | France | Singlecenter | Paper | Double-blind | Yes | Yes | Yes | ACCP/SCCM criteria | Mixed | Shock-reversal |
Briegel and colleagues [39] | 1999 | 1996 | Germany | Singlecenter | Paper | Double-blind | Yes | Yes | No | ACCP/SCCM criteria | Mixed | Shock-reversal |
Chawla and colleagues [47] | 1999 | NA | USA | Singlecenter | Abstract | Double-blind | NA | NA | NA | NA | NA | Shock-reversal |
Yildiz and colleagues [45] | 2002 | 1999 | Turkey | Singlecenter | Paper | Double-blind | No | No | No | ACCP/SCCM criteria | Medical | 28-day mortality |
Annane and colleagues [36] | 2002 | 1999 | France | Multicenter | Paper | Double-blind | Yes | Yes | No | Documented evidence of infection; fever/hypothermia; SBP < 90 mmHg, despite fluid and vasopressors; decreased organ perfusion; mechanical ventilation | Mixed | 28-day survival distribution in corticorophin non-responders |
Tandan and colleagues [44] | 2005 | NA | India | Singlecenter | Abstract | Double-blind | NA | NA | NA | NA | Â | 28-day mortality |
Oppert and colleagues [ 42] | 2005 | NA | Germany | Singlecenter | Paper | Double-blind | Yes | NA | NA | Tachycardia; Fever/hypothermia; Positive culture; SBP < 90 mmHg with CVP ≥10 mmHg,; vasopressors | Medical | Time to vasopressor cessation |
Sprung and colleagues [8] | 2008 | 2005 | Europe | Multicenter | Paper | Double-blind | Yes | Yes | Yes | Clinical evidence of infection; evidence of systemic response to infection; shock (within 72 hours), SBP <90 mmHg despite fluid infusion or vasporessors; inadequate organ perfusion/dysfunction | Mixed | 28-day mortality in corticorophin non-responders |