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International Symposium on Intensive Care and Emergency Medicine Update / March 17th 2015

 

Hello

Welcome to a supplemental Critical Care Reviews Newsletter, bringing you the three major research studies presented at the 2015 Brussels meeting this afternoon, and simultaneously published in the New England Journal of Medicine today. All three papers are currently open access.

 

ProMISe

In a pragmatic, open, parallel group, randomized controlled trial, Mouncey and colleagues compared an early goal-directed therapy protocol for the first six hours of management (n=630) with usual care (n=630), in 1260 patients with early septic shock across 56 English hospitals, and found (EGDT vs UC):

for clinical outcomes

  • no difference in
    • 90 day mortality (1° outcome):
      • 29.5% vs 29.2%
        • relative risk in the EGDT group, 1.01; 95% CI  0.85 to 1.20; P = 0.90
        • absolute risk reduction in the EGDT group of −0.3 %; 95% CI −5.4 to 4.7
  • worsened organ failure with EGDT
    • SOFA at 6 hours
      • 6.4±3.8 vs 5.6±3.8  (incremental effect 0.8; 95% CI 0.5 to 1.1; P<0.001)
    • SOFA at 72 hours
      • 4.0±3.8 vs 3.7±3.6 (incremental effect 0.4; (95% CI −0.0 to 0.8; P= 0.056)
  • increased resource usage with EGDT:
    • vasoactive drugs
      • 53.3% vs 46.6% at 6 hours
    • red-cell transfusions
      • 8.8% vs 3.8% at 6 hours;
      • 12.6 vs 8.5% at 6 to 72 hours
    • advanced circulatory support
      • 37.0% vs 30.9%   (incremental effect 1.19, 95% 1.02 to 1.40; P= 0.026)
    • length of stay in ICU (median / IQR)
      • 2.6 (1.0 to 5.8) days vs 2.2 (0.0 to 5.3) days; P=0.005
  • no benefit for EGDT was seen in any subgroup
  • no difference in adverse events
    • 4.8% vs 4.2% P=0.58

for cost effectiveness

  • no difference in
    • Health-related quality of life on EQ-5D at 90 days
      • 0.609±0.319 vs  0.613±0.312 (incremental effect −0.004, 95% CI −0.051 to 0.044; p= 0.88)
    • Quality-adjusted life-yr up to 90 days
      • 0.054±0.048 vs 0.054±0.048 (incremental effect −0.001, 95% CI −0.006 to 0.005; P =0.85)
    • Costs up to 90 days (P=0.26)
      • Pounds: 12,414±14,970 vs 11,424±15,727 (incremental effect 989, 95% CI −726 to 2,705)
      • Dollars: 17,647±21,280 vs 16,239±22,356 (incremental effect 1,406, 95% CI −1,032 to 3,845)

Full Text:  Mouncey. Trial of Early, Goal-Directed Resuscitation for Septic Shock. (ProMISe Trial). N Engl J Med 2015;epublished March 17th

 

ABLE

In a parallel group, blinded, randomized controlled trial, Lacroix and colleagues compared transfusion of fresh red cells (stored for < 8 days, n=1211) with standard-issue red cells (the oldest compatible units available in the blood bank, n=1219) in 2,400 critically ill, and found:

  • a significant difference in red cell age between groups:
    • 6.1±4.9 days vs 22.0±8.4 (P<0.001)
  • no difference in 90 day mortality (1° outcome)
    • 37.0%  vs 35.3%
      • absolute risk difference, 1.7 %; (95% CI  –2.1 to 5.5)
      • hazard ratio for death in the fresh-blood group 1.1 (95% CI 0.9 to 1.2; P=0.38)
  • no significant differences in any 2° outcomes
    • death
      • ICU
        • 26.7% vs 24.2%;  absolute risk difference 2.5% (95% CI -1.0 to 5.9)
      • Hospital
        • 33.3% vs 31.9%; absolute risk difference 1.4% (95% CI -2.3 to 5.1)
      • Day 28
        • 30.6% vs 28.8%; absolute risk difference 1.7% (95% CI -1.9 to 5.4)
    • duration of
      • mechanical ventilation
        • 15±18 vs 14.7±14.9 days; mean difference 0.3 (−1.1 to 1.6)
      • hemodynamic support
        • 7.1±10.2 vs 7.5±11.2 days; mean difference −0.4 (−1.2 to 0.5)
      • renal support
        • 2.5±10.1 vs 2.3±8.3 days; mean difference 0.2 (−0.6 to 0.9)
    • length of stay 
      • ICU
        • 15.3±15.4 vs 15.3±14.8; mean difference 0.1 (−1.2 to 1.3)
      • Hospital
        • 34.4±39.5 vs 33.9±38.8; mean difference 0.5 (−2.6 to 3.7)
    • transfusion reactions
      • 4 patients vs 6 patients
    • subgroup analyses

Full Text:  Lacroix. Age of Transfused Blood in Critically Ill Adults (ABLE Study). N Engl J Med 2015;epublished March 17th

 

SIRS Criteria in Sepsis

Kaukonen and colleagues tested the utility of the SIRS criteria for the identification of severe sepsis using data from 1,171,797 patients, of whom 109,663 had infection and organ failure, over a 14 year period (2000 to 2013) from 172 ICUs in New Zealand and Australia, and found:

  • Percentage breakdown
    • SIRS-positive severe sepsis: 87.9% (n=96,385)
    • SIRS-negative severe sepsi: 12.1% (n=13,278) 
  • patients with SIRS-positive severe sepsis were
    • younger
      • 65.8 vs 68.3; p<0.001
    • more severely ill
      • APACHE III score
        • 73.7±30.1 vs 56.7±26.1; p<0.001
    • suffered higher mortality
      • 24.5% vs 16.1%; p<0.001
    • suffered greater organ failure
      • septic shock
        • 58% vs 42.2%; p<0.001
      • acute renal failure
        • 18.9% vs 11.7%; p<0.001
    • reduced rates of
      • mechanical ventilation
        • 53.3% vs 55.2%; p<0.001
  • both groups had decreasing mortality over this time period
    • SIRS-positive group:
      • from 36.1% to 18.3%, p<0.001
    • SIRS-negative group:
      • from 27.7% to 9.3%, p<0.001
  • adjusted mortality increased linearly with each additional SIRS criterion
    • odds ratio for each additional criterion 1.13 (95% CI 1.11 to 1.15; P<0.001)
    • without any transitional increase in risk at a threshold of two SIRS criteria
  • The authors concluded
    • "The need for two or more SIRS criteria to define severe sepsis excluded one in eight otherwise similar patients with infection, organ failure, and substantial mortality, and failed to define a transition point in the risk of death."

Full Text:  Kaukonen. Systemic Inflammatory Response Syndrome Criteria in Defining Severe Sepsis. N Engl J Med 2015;epublished March 17th

 

Until the weekend

Rob

 

 

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