Journal Club Summary
Methodology Score: 3.5/5
Usefulness Score: 2.5/5
Caironi P, Tognoni G, et al. the ALBIOS Study Investigators.
N Engl J Med. 2014 Mar 18.
This was an open-label RCT of 1,800 ICU patients with severe sepsis or septic shock, examining whether targeting a certain serum albumin level with albumin supplementation improved: mortality at 28 and 90 days, presence and degree of organ dysfunction, and length of stay in hospital and in ICU. Giving albumin vs. saline did not improve any of these a priori outcomes. JC attendees agreed that while the study was well-designed, it had a significant amount of crossover with no sensitivity analysis, and targeting a serum albumin concentration in the ED is not practical.
By: Dr. Ashley Krywenky
Stratification of Randomization by Timing of Enrolment
Block randomization offers the benefit of ensuring overall balance of groups when you have multiple centers or clinically defined subgroups. Another approach is to randomize by the timing of enrolment when this could influence the outcome. In this study, the authors stratified their enrolment to account for early and later enrolments given that sepsis is a time sensitive condition. The sensitivity analysis for these strata reassure the reader that the overall observed effect was not influenced by timing of enrolment.
By: Lisa Calder