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  • ProMISe Original

    • ProMISe



    Clinical Question


    Does protocolized hemodynamic management (early, goal-directed therapy [EGDT]) in early septic shock improve outcomes compared with usual care?

    Bottom Line


    In adults with early signs of septic shock, EGDT including intravenous antibiotics and adequate fluid resuscitation does not lead to improved outcomes compared with usual resuscitation care.

    Major Points




    Guidelines




    Design


    - Pragmatic, open, multicenter, parallel-group, randomized, controlled trial
    - N=1,260 patients with early septic shock
    - Intervention: EGDT (n=630)
    - Control: Usual resuscitation care (n=630)
    - Setting: 56 hospitals in England
    - Enrollment period: February 16, 2011, to July 24, 2014
    - Primary outcome: All-cause mortality at 90 days

    Population


    Inclusion Criteria:
    - Adults (≥18 years)
    - Presentation within 6 hours after emergency department visit
    - Infection, systemic inflammatory response syndrome criteria, and hypotension or hyperlactatemia

    Exclusion Criteria:
    - Criteria not mentioned in the provided abstract

    Baseline Characteristics
    - Similar in both groups
    - Refractory hypotension criteria met in approximately 55% of patients in both groups
    - Hyperlactatemia criteria met in 65.4% in EGDT and 63.7% in usual care
    - Mean first ScvO2 was 70±12%

    Interventions


    - EGDT group: 6-hour resuscitation protocol guided by central venous pressure, mean arterial pressure, central venous oxygen saturation
    - Usual care group: Treatment decisions made by the treating clinicians, no protocolized resuscitation

    Outcomes


    - Primary Outcome: No significant difference in 90-day all-cause mortality (EGDT 29.5% vs. usual care 29.2%, RR 1.01, 95% CI 0.85 to 1.20, P=0.90)
    - Increased treatment intensity in the EGDT group, including use of intravenous fluids, vasoactive drugs, and red-cell transfusions
    - No differences in health-related quality of life or rates of serious adverse events
    - Costs were higher on average in the EGDT group

    Criticisms


    - The intervention could not be blinded.
    - Only one-third of eligible patients were enrolled.
    - Mortality rates were lower than anticipated.

    Funding


    - Funded by the United Kingdom National Institute for Health Research Health Technology Assessment Programme

    Further Reading


    - ProCESS and ARISE trials, which also assessed EGDT in septic shock.