ALBIOS

ALBIOS: Albumin Replacement in Patients with Severe Sepsis or Septic Shock

Caironi et al for the ALBIOS Study Investigators. N Engl J Med 2014; 370(15):1412–21.

Clinical Question

  • In adults with severe sepsis or septic shock, does 20% albumin solution with crystalloid fluid compared to crystalloid fluid alone reduce death with 28 days?

Design

  • Randomised, controlled clinical trial
  • Stratified according to participating ICU and time between onset of sepsis and randomisation (<6 hours vs >6 hours)
  • Open-label (non-blinded)

Setting

  • 100 intensive care units in Italy
  • August 2008 to February 2012

Population

  • Inclusion: adults who met the clinical criteria for severe sepsis (SIRS + proven or suspected infection + at least one organ dysfunction as measured by SOFA score)
  • Exclusions: Head injury, congestive heart failure, over 24 hours since inclusion criteria met, objection to blood products, albumin indicated for specific clinical reason.
  • 1818 participants

Intervention

  • 20% albumin and crystalloid solution
    • 300ml of 20% albumin daily to maintain serum albumin at 30 g/l or more
    • Crystalloid as clinically indicated at physician’s discretion
    • 20% albumin accounted for median daily average of 4.3% of the total administered fluid
    • Median total daily fluid was 3,738ml for first 7 days (compared with control this was a non-statistically significant difference [p=0.10])

Control

  • Crystalloid as clinically indicated at physician’s discretion
  • Median total daily fluid was 3,825ml for first 7 days

Outcome

  • Primary outcome: mortality at 28 days was not different between groups
    • 31.8% in albumin group versus 32.0% in crystalloid group; RR 1.00 (CI 0.87–1.14; p=0.94).
  • Secondary outcome: mortality at 90 days was not different between groups

Authors’ Conclusions

  • The addition of albumin to crystalloids during the first 28 days of treatment to maintain a serum albumin level of 30 g/l or more is safe, but does not provide a survival advantage over crystalloids alone over a follow-up period of 90 days

Strengths

  • Pragmatic study directly relevant to clinical practice.
  • Only 29 participants lost-to-follow-up (1.6%), which is well below primary outcome rate (minimal attrition bias).

Weaknesses

  • Open-label, non-blinded methodology may have influenced clinicians’ decisions, which may have biased toward either intervention or control.
  • Lower incidence of death compared to anticipated rate (45% used in power calculation) may have lead to type 2 error (failure to detect a true positive outcome).

The Bottom Line

  • The use of 20% albumin in adults with severe sepsis will improve haemodynamic indices, but will not reduce mortality. It’s use is safe but not recommended for routine fluid resuscitation. Targeting a serum albumin of 30g/l or more does not appear to have a survival advantage.

Links

Full text pdf not available without subscription / abstract / doi: 10.1056/NEJMoa1305727

Editorials, Commentaries or Blogs

  • None listed

Metadata

Summary author: @DuncanChambler
Summary date: May 2014
Peer-review editor: @stevemathieu75

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