ALBIOS Trial

NEJM

April 10, 2014

Albumin Replacement in Patients with Severe Sepsis or Septic Shock.

What was the research question?

  • Does the replacement of albumin in patients with severe sepsis improve mortality compared to no replacement?


How did they do it?

  • A multicenter, open label trial in 100 intensive care units in Italy.

  • Total of 1818 patients with severe sepsis were randomized to receive either 20% albumin to target serum albumin concentration of 30 g/L (895 patients), or crystalloid solution with no albumin replacement (900 patients).

  • The primary outcome was mortality at 28 days after randomization.

  • Secondary outcome was 90 day mortality, number of patients with the organ dysfunction, and length of stay in the ICU and the hospital.


What did they find?

  • Mean arterial pressure was higher in the albumin group compared to the control group (p=003). Similarly, patients in the albumin group had a lower net fluid balance (P<0.001).

  • Mortality at 28 days was not significantly different between the albumin group and the crystalloid group (31.8% versus 32%, P=0.94).

  • Mortality at 90 days was also not significantly different between the two groups ( 41.1% versus 43.6% , p=0.29).

  • No significant differences in other secondary outcomes were observed between the two groups.

  • Post hoc analysis revealed that patients 90-day mortality in 1121 patients with septic shock was 43.6% in the albumin group compared to 49.9% in the control group (p=0.03).


Are there any limitations?

  • Open-label, non-blinded study with possibility of bias towards      either albumin group or the control.

  • High risk of type II error (failure to detect true difference in mortality) as the power of the study was calculated based on      a mortality of 45%.


What does it mean?

  • Mortality at 28 days or 90 days was not different in patients with severe sepsis and albumin replacement compared to crystalloids alone.

ALBIOS Trial