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  • SAFE Original
  • SAFE



    Contents


    1 Clinical Question
    2 Bottom Line
    3 Major Points
    4 Guidelines
    5 Design
    6 Population
    6.1 Inclusion Criteria
    6.2 Exclusion Criteria
    6.3 Baseline Characteristics
    7 Interventions
    8 Outcomes
    8.1 Primary Outcome
    8.2 Secondary Outcomes
    9 Funding
    10 Further Reading

    Clinical Question


    In ICU patients requiring intravascular volume resuscitation, does the choice of resuscitation fluid (albumin or saline) affect survival?

    Bottom Line


    In ICU patients requiring fluid resuscitation, there is no significant difference in 28-day mortality rates between those treated with albumin and those treated with saline.

    Major Points




    Guidelines




    Design


    Multicenter, double-blind, parallel group, randomized, placebo-controlled trial
    N=6,997
    Albumin group (n=3,497)
    Saline group (n=3,500)

    Population


    Inclusion Criteria: ICU patients 18 years or older requiring fluid administration to maintain or increase intravascular volume.
    Exclusion Criteria: Patients admitted post-cardiac surgery, post-liver transplantation, or for treatment of burns.
    Baseline Characteristics: Similar baseline characteristics between both groups, including APACHE II scores and organ failure assessment.

    Interventions


    Patients were randomized to receive either 4% albumin or normal saline for intravascular fluid resuscitation in the 28 days following randomization.

    Outcomes


    Primary Outcome: Death from any cause within 28 days of randomization.
    Secondary Outcomes: Duration of mechanical ventilation, duration of renal-replacement therapy, length of ICU and hospital stay, rate of new single-organ, and multiple-organ failure.

    Funding


    Supported by multiple health boards, departments, councils, and CSL (manufacturers of Albumex).

    Further Reading


    The full text is available from the The New England Journal of Medicine as linked in the original article.