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.