Randomized trial evaluating serial protein C levels in severe sepsis patients treated with variable doses of drotrecogin alfa (activated)

Table 4 Twenty-eight-day mortality by infusion duration in the moderate protein C deficiency population

	Alternative therapy Moderate protein C deficiency 24 μg/kg/hr			Standard therapy Moderate protein C deficiency 24 μg/kg/hr
Duration of study drug infusion	Number of patients	Number of deaths	Percent deaths	Number of patients	Number of deaths	Percent deaths
Total	172	43	25.0	173	20	11.6
≥97 hours*^†	71	17^a	23.9	70	8^b	11.4
< 97 hours^†	71	20^c	28.2	65	9^d	13.8
Patients with shorter infusions of DAA ^‡	30	6^e	20.0	38	3^f	7.9

Cause of death:^aSepsis induced multiorgan failure (n = 5); respiratory failure (n = 4); refractory septic shock (n = 3); hemorrhage (hepatic artery) (n = 1); disseminated malignancy (n = 1); ischemic gut (n = 1); ischemic cardiomyopathy (n = 1); shock of unknown origin (n = 1).^bSepsis induced multi-organ failure (n = 5); respiratory failure (n = 1); refractory septic shock (n = 1); unknown (n = 1). ^cSepsis induced multi-organ failure (n = 10); respiratory failure (n = 1); refractory septic shock (n = 8); cardial and respiratory arrest (n = 1).^dSepsis induced multi-organ failure (n = 5); respiratory failure (n = 2); refractory septic shock (n = 0); primary cardiac arrhythmia (n = 1); hypoxic brain injury (n = 1).^eSepsis induced multi-organ failure (n = 3); respiratory failure (n = 2); refractory septic shock (n = 1).^fSepsis induced multi-organ failure (n = 1); respiratory failure (n = 1); refractory septic shock (n = 1). *97 hours was used as cut off point as standard infusion time was 96 ± 1 hr. ^†Excluding patients with shorter infusions of drotrecogin alfa (activated) (DAA). ^‡Alternative patients potentially switched to a placebo infusion <97 hours because of normalization of protein C levels between 48 to 84 hours preamendment, while standard therapy patients received 96 hours of drotrecogin alfa (activated).

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