ALBIOS TRIAL PDF

Abstract Background A 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. We investigated how the populations defined according to Shock-2 and Shock-3 differed and whether the albumin benefit would be confirmed. We compared group size, physiological variables and day mortality between patients defined by Shock-2 and Shock-3 and between the albumin and crystalloid treatment groups. Results We 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. Albumin decreased mortality in Shock-2 patients compared to crystalloids

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Corresponding author. Received May 24; Accepted Aug This article has been cited by other articles in PMC. Abstract Background A 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. We investigated how the populations defined according to Shock-2 and Shock-3 differed and whether the albumin benefit would be confirmed.

We compared group size, physiological variables and day mortality between patients defined by Shock-2 and Shock-3 and between the albumin and crystalloid treatment groups. Results We 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. Albumin decreased mortality in Shock-2 patients compared to crystalloids In patients defined by Shock-3 a similar benefit was observed for albumin with a Conclusions The Sepsis-3 definition reduced the size of the population with shock and showed a similar effect size in the benefits of albumin.

Trial registration ClinicalTrials. Registered on 30 June Given that sepsis is a syndrome rather than a disease, the individual response to treatment may be heavily confounded by its underlying etiology and pathophysiologic phenotype, which represent an unavoidable source of heterogeneity in patients with sepsis.

An additional source of heterogeneity however, derives from the severity of sepsis. Indeed, various clinical definitions of septic shock identify patients with different severity and mortality risk, depending on the criteria they employ.

Therefore, efforts have been made to select criteria that identify a more homogeneous subset of septic patients with a greater mortality risk than the one associated to sepsis alone.

However, the application of similar criteria led to the enrollment of remarkably different populations into clinical trials in different countries, with striking differences in mortality rates [ 4 ]. Indeed, 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 ].

In this study, we reanalyzed the results from the ALBIOS study [ 1 ] - which in compared the efficacy of the administration of albumin and crystalloids versus crystalloids alone in patients with septic shock - based on the new definition of septic shock. Our aim was to report differences in the populations classified as Shock-2 or Shock-3, highlighting possible advantages and disadvantages of this new definition. As shown, the differences were related to the availability of lactate levels at baseline and the lactate threshold.

Accordingly, we compared the patient subpopulations defined on the basis of Shock-2 patients and Shock-3 patients criteria in terms of physiological, gas exchange, hemodynamic and outcome variables. Table 1.

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Volume Replacement With Albumin in Severe Sepsis (ALBIOS)

Corresponding author. Received May 24; Accepted Aug This article has been cited by other articles in PMC. Abstract Background A 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. We investigated how the populations defined according to Shock-2 and Shock-3 differed and whether the albumin benefit would be confirmed.

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ALBumin Italian Outcome Septic Shock-BALANCED Trial (ALBIOSS-BALANCED) (ALBIOSS-BAL)

Volume replacement will be performed in both the treated and the control group according to the "early-goal directed therapy". Albumin solutions will be infused over a period of 3 hours. Further infusion of crystalloids will be allowed, when necessary, according to the clinical judgment. No infusion of colloids, other than albumin, will be admitted. Albumin administration will be restricted to emergency use, as clinically judged and documented according to the standard criteria of each participating unit. No other colloids will be allowed.

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Septic shock-3 vs 2: an analysis of the ALBIOS study

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