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Table 1 Comparison of (a) targeted population, (b) experimental treatments of four trials on corticosteroids for septic shock

From: Design and conduct of the activated protein C and corticosteroids for human septic shock (APROCCHSS) trial

  Ger-Inf-05 CORTICUS APROCCHSS ADRENALS
(a)
Expected sample size 300 800 1240 3800
Actual sample size 300 500 1241 ?
Time window for inclusion since onset of shock 3 h then protocol amended for 8 h 72 h 24 h 24 h
Age ≥18 years ≥18 years ≥18 years ≥18 years
Shock criteria SBP < 90 mm Hg for at least 1 h despite adequate fluid replacement and >5 μg/kg/h of dopamine or epinephrine or norepinephrine;
Arterial lactate >2 mmol/l
SBP < 90 mmHg or decrease >50 mmHg in SBP in previous hypertensive patients despite adequate fluid replacement or need for vasopressors to maintain SBP ≥ 90 mmHg
Administration of vasopressor for ≥1 h
Norepinephrine or epinephrine at a rate ≥0.25 µg/kg/min or ≥1 mg/h) or any other vasopressor to maintain SBP ≥ 90 mmHg or MBP ≥ 65 mmHg
Administration of vasopressors for ≥6 h
Vasopressors or inotropes to maintain a SBP > 90 mmHg, or MBP > 60 mmHg, or a MBP target set by the treating clinician for maintaining perfusion
Administration of vasopressors or inotropes for =4 h
Mechanical ventilation as a mandatory entry criteria Yes No No Yes
Organ failure Urinary output of <0.5 ml/kg for ≥1 h
Or PaO2/FIO2 < 280 mmHg
Urine output <0.5 ml/kg/h for ≥1 h
Or pH < 7.3, or arterial base deficit ≥5.0 mmol/l, or arterial lactate >2 mmol/l
Or PaO2/FIO2 < 280 in the absence of pneumonia, and <200 in the presence of pneumonia
Or platelet count ≤100,000 cells/mm3
Or Glasgow Coma Scale <14 or acute change from baseline)
Sequential Organ Failure Assessment (SOFA) score ≥3 for ≥2 organs for ≥6 consecutive hours Not mentioned
Non-responders to the Synacthen test as the primary subgroup of interest Yes Yes Yes No
(b)
Type of corticosteroids Hydrocortisone hemisuccinate and 9-α-fludrocortisone Hydrocortisone hemisuccinate Hydrocortisone hemisuccinate and 9-α-fludrocortisone Hydrocortisone
Dose per day Hydrocortisone 200 mg
Fludrocortisone 50 µg
200 mg Hydrocortisone 200 mg
Fludrocortisone 50 µg
200 mg
Route of administration Hydrocortisone: four intravenous bolus of 50 mg
Fludrocortisone: 50 µg via the nasogastric tube
Four intravenous bolus of 50 mg Hydrocortisone: four intravenous bolus of 50 mg
Fludrocortisone: 50 µg via the nasogastric tube
Intravenous continuous infusion rate without loading dose
Duration Seven days at full dose Five days at full dose then tapered to 50 mg intravenously every 12 h for days 6 to 8, 50 mg every 24 h for days 9 to 11, and then stopped Seven days at full dose Seven days at full dose, while in the ICU
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