• ProCESS Trial: Protocol-Based Care for Early Septic Shock

    by Alan Batt. Last modified: 23/03/14

    sepsis

     Summary

    • Multi centre randomised trial
    • 1341 patients enrolled
      • 439 were randomly assigned to protocol-based EGDT (early goal-directed therapy)
        • 60-day mortality rate – 21.0% (92)
      • 446 to protocol-based standard therapy
        • 60-day mortality rate – 18.2% (81)
      • 456 to usual care
        • 60-day mortality rate – 18.9% (86)
    • Overall 60 day mortality was approximately 20% for all groups
    • No significant differences in 90-day mortality
    • No significant differences in 1-year mortality
    • No significant differences in the need for organ support
    • Central line monitoring of central venous oxygen saturation is not necessary for improving survival
    • Sepsis outcomes have improved over the past number of years
    • Early recognition and early antibiotic administration remain fundamental components of care in sepsis
    • In this study, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes.
    • Of the three care pathways, no one resuscitative path is bad or better.

    Limitations

    • Resuscitation strategies differed significantly amonst groups – i.e. all were treated differently
      • IV fluid volumes delivered differed significantly among the groups (2.8 litres in the protocol-based EGDT group, 3.3 litres in the protocol-based standard-therapy group, and 2.3 litres in the usual-care group)
      • Pressor amounts delivered differed signicantly between to protocol groups and the usual care group (54.9% in the protocol-based EGDT group, 52.2% in the protocol-based standard-therapy group, 44.1% in the usual-care group)
    • Protocol adherence across the 31 centres may have varied slightly
    • Septic shock occurs in a heterogeneous population, and care before randomization can be variable – differences in prehospital care cannot be accounted for.
    • Study was carried out in a setting where sepsis is aggressively sought and treated early – results may not be applicable to settings that have poor recognition & treatment rates.
    • In-hospital mortality among patients requiring life support is strongly influenced by varying practices regarding the withdrawal of care.
    • Results are not applicable to pre-hospital setting as all patients enrolled in trial were in-hospital patients.
    • Results from ARISE and PROMISE trials will reveal whether particular strategies were more effective in specific subgroups.

     

     
    The ProCESS Investigators. A Randomized Trial of Protocol-Based Care for Early Septic Shock. N Engl J Med. 2014 Mar 18. PMID: 24635773.

     

    Abstract

    Background

    In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary.

    Methods

    In 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support.

    Results

    We enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support.

    Conclusions

    In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes.

    Trial Registration

    ClinicalTrials.gov, NCT00510835

    References

     
    1.

    The ProCESS Investigators. A Randomized Trial of Protocol-Based Care for Early Septic Shock. N Engl J Med. 2014 Mar 18. PMID: 24635773.

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    Alan Batt

    Alan Batt

    Paramedic, educator, researcher
    Alan is a critical care paramedic, paramedic educator and prehospital researcher, currently working around the world as an educator and researcher. He has previously worked and studied across Europe, North America and the Middle East. He holds a Graduate Certificate in Intensive Care Paramedic Studies, and an MSc in Critical Care. His main interests are in care of the elderly, end-of-life care, patient safety, professionalism (including role and identity), and paramedic education.

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