Table 5 Summary of Methodological Comparisons
| Â | The trio of EGDT trials | EGDT study |
|---|---|---|
Requisite for enrollment and defined as usual care | Screening using SIRS Fluid challenge Lactate screening for cryptic shock Early antibiotic administration within 6 h encouraged (ProCESS) | No previous standards. Developed from a series of studies over a decade. |
Enrollment | Enrollment (8/site/year) 2- to 12-h window of enrollment in the ED Weekdays and no weekends (ProMISe) Exclusion rate of 43 to 67 % | Single center 1–2 h enrollment |
Fluid challenge | Fluid challenge—1 liter or surrogate | 20–30 mL/kg |
Trial duration and timing | Trials began 7–8 years after EGDT (2008–2015) Duration ranging between 4 and 8 years SSC guidelines were published in 2004, 2008, and 2012 | No existing sepsis protocols |
Blinding | Open label study in the ICU | ICU was blinded to care provided in the ED |
Trial conduct | Duration of ED stay less than 3 h Majority of care provided in ICU Delayed resuscitation bundle completion after 6 h not tested High volume and tertiary care centers CVP placement over 50 % of control groups in trio of EGDT trials A reduction in sample size after interim analysis low mortality | Performed in ED only 6–8 h in the ED Delayed care improves outcomes |
Co-morbidities | Fewer Younger patients | Increased cardiovascular, liver, neurologic and renal failure |
Mechanical ventilation | Rate of 26Â % No delayed increase after enrollment Protective lung strategies | Rate of 54Â % No protective lung or fluid management strategies Increase in delayed MV in the control group. |
Illness severity | Acute pulmonary edema excluded Acute lung injury excluded | Lower temperature Lower PaCO2 More tachypnea |
Hemodynamic phenotype | Normal ScvO2 and CVP at baseline (all groups received similar fluids as the original EGDT treatment group from hospital arrival to 6 hours) 50 % more vasopressors (vasodilatory) in the trio of EGDT trials Steroid use 8–37 % | Lower ScvO2 Higher lactate Lower CVP No steroid use |
Sudden cardiopulmonary events | Not a predominant feature | Significant reduction from 20 to 10Â % |
Sources of improved care | Pre-existing sepsis protocols, pre-hospital care, sepsis alerts and screens, rapid response systems, telemedicine, glucose control, ventilator strategies, hemoglobin strategies, palliative care, national limits on ED length of stay (Australia and United Kingdom), ultrasound | Â |
Generalizability and external validity | Performed in academic centers in industrialized countries Specialized care delivery | EGDT replicated in community and academic centers worldwide |