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Table 5 Summary of Methodological Comparisons

From: Early goal-directed therapy in severe sepsis and septic shock: insights and comparisons to ProCESS, ProMISe, and ARISE

  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 26 %
No delayed increase after enrollment
Protective lung strategies
Rate of 54 %
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 10 %
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  
Generalizability and external validity Performed in academic centers in industrialized countries
Specialized care delivery
EGDT replicated in community and academic centers worldwide
  1. CVP central venous pressure, EGDT Early Goal-Directed Therapy, ED emergency department, ICU intensive care unit, MV mechanical ventilation, PaCO 2 partial pressure of carbon dioxide, ProCESS Protocolized Care for Early Septic Shock, ProMISe Protocolized Management in Sepsis, ScvO 2 central venous oxygen saturation, SIRS systemic inflammatory response syndrome, SSC Surviving Sepsis Campaign