Abstract
BackgroundA reanalysis of the ALBIOS trial suggested that patients with septic shock - defined by vasopressor-dependent hypotension in the presence of severe sepsis (Shock-2) - had a survival benefit when treated with albumin. The new septic shock definition (Shock-3) added the criterion of a lactate threshold of 2 mmol/L. We investigated how the populations defined according to Shock-2 and Shock-3 differed and whether the albumin benefit would be confirmed.MethodsThis is a retrospective analysis of the ALBIOS study, a randomized controlled study conducted between 2008 and 2012 in 100 intensive care units in Italy comparing the administration of 20% albumin and crystalloids versus crystalloids alone in patients with severe sepsis or septic shock. We analyzed data from 1741 patients from ALBIOS with serum lactate measurement available at baseline. We compared group size, physiological variables and 90-day mortality between patients defined by Shock-2 and Shock-3 and between the albumin and crystalloid treatment groups.ResultsWe compared the Shock-2 and the Shock-3 definitions and the albumin and crystalloid treatment groups in terms of group size and physiological, laboratory and outcome variables. The Shock-3 definition reduced the population with shock by 34%. The Shock-3 group had higher lactate (p < 0.001), greater resuscitation-fluid requirement (p = 0.014), higher Simplified Acute Physiology Score II (p < 0.001) and Sepsis-related Organ Failure Assessment scores (p = 0.022), lower platelet count (p = 0.002) and higher 90-day mortality (46.7% vs 51.9%; p = 0.031). Albumin decreased mortality in Shock-2 patients compared to crystalloids (43.5% vs 49.9%; 12.6% relative risk reduction; p = 0.04). In patients defined by Shock-3 a similar benefit was observed for albumin with a 11.3% relative risk reduction (48.7% vs 54.9%; 11.3% relative risk reduction; p = 0.22).ConclusionsThe Sepsis-3 definition reduced the size of the population with shock and showed a similar effect size in the benefits of albumin. The Shock-3 criteria will markedly slow patients’ recruitment rates, in view of testing albumin in septic shock.Trial registrationClinicalTrials.gov, number NCT00707122. Registered on 30 June 2008.
Highlights
A reanalysis of the ALBIOS trial suggested that patients with septic shock - defined by vasopressordependent hypotension in the presence of severe sepsis (Shock-2) - had a survival benefit when treated with albumin
In Discussion The main finding of our study was that Shock-3 criteria applied to the ALBIOS population selected a smaller but more severely ill population affected by higher mortality
The relative risk reduction in mortality observed in septic patients defined by Shock-2 and treated with albumin, compared to those treated with crystalloids, remained similar when applying the Sepsis-3 criteria (12.6% vs 11.3%) but was no longer significant, due to the smaller size of the septic shock group
Summary
A reanalysis of the ALBIOS trial suggested that patients with septic shock - defined by vasopressordependent hypotension in the presence of severe sepsis (Shock-2) - had a survival benefit when treated with albumin. Various clinical definitions of septic shock identify patients with different severity and mortality risk, depending on the criteria they employ. The mortality was remarkably lower in trials conducted in the USA (32%) [7] or in Australia and New Zealand (18.8%) [8] These trials highlighted the fact that the “Sepsis 2” criteria for septic shock were inadequate to identify patients with comparable severity and raised the issue of the results of these trials not being generalizable to the “real world” population (i.e., external validity). In 2016, a new consensus definition in an effort to increase predictive validity - proposed the need for both vasopressor-dependent hypotension and serum lactate greater than 2 mmol/L after adequate fluid resuscitation to define septic shock (Shock-3 definition) [9]. The association between serum lactate levels and mortality is one of the oldest and most consistent relationship in intensive care and its inclusion in the definition of shock is based on the clear correlation between excess lactate level and severity of illness, the lactate level being a crude surrogate for cellular and metabolic abnormalities [10]
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