Table 3.
Infectious Diseases Society of America’s Proposed Changes to the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) Measure
| Current SEP-1 Measure | IDSA Recommendations and Rationale | IDSA Proposed SEP-1 |
|---|---|---|
| Definitions | ||
| Severe sepsis •Documentation of suspected or confirmed infection, AND •≥2 SIRS criteria, AND •≥1 organ dysfunction (8 possible criteria)a •OR documentation of suspected severe sepsis (regardless of clinical criteria) |
•Eliminate from SEP-1 (weak evidence for necessity of immediate antibiotics in sepsis without shock; many potential noninfectious mimickers may be treated with antibiotics unnecessarily and lead to promoting widespread unnecessary antibiotic prescribing; complex and heterogeneous criteria lead to variability in abstraction) | … |
| Septic shock •Documentation of suspected or confirmed infection, AND •≥2 SIRS criteria, AND •Persistent hypotension after 30 cc/ kg of fluids, or lactate ≥4.0 mmol/L •OR documentation of suspected septic shock (regardless of clinical criteria) |
•Eliminate SIRS requirement (shock and suspected infection are sufficient evidence of septic shock; SIRS criteria add complexity to time zero abstraction) •Modify persistent hypotension definition to more objective and reproducible clinical criteria (30 cc/kg not evidence-based and difficult to abstract) •Eliminate documentation of possible or suspected septic shock as potential trigger (poor proxy for clinical recognition; does not take into account level of suspicion) |
•Documentation of suspected or confirmed infection, AND •Objective and reproducible clinical criteria for shock (precise “time zero” definition warrants discussion with other expert task forces) |
| Management bundles | ||
| 3-hour bundle | ||
| •Measure lactate level | •Eliminate (not specific for infection; clear evidence of clinical benefit is lacking) | … |
| •Blood cultures (prior to antibiotics) | •Agree | •Blood cultures (prior to antibiotics) |
| •Broad-spectrum antibiotics | •Agree but decrease time requirement for septic shock (strong evidence that each hour delay increases risk of death) | •Administer broad-spectrum antibiotics within 1 hour of septic shock “time zero” •Report time interval between antibiotic order and delivery for the first broad-spectrum antibiotic |
| •30 cc/kg intravenous fluids for hypotension or lactate ≥4.0 mmol/L | •Defer to other expert task forces | … |
| 6-hour bundle | ||
| •Remeasure lactate if initial level >2.0 mmol/L | •Eliminate (evidence of clinical benefit is lacking) | … |
| •Vasopressors to target mean arterial pressure ≥65 mmHg for persistent hypotension after 30 cc/kg fluids | •Defer to other expert task forces | … |
| •Document repeat volume status and perfusion assessment for septic shock | •Defer to other expert task forces | … |
Abbreviations: IDSA, Infectious Diseases Society of America; SEP-1, Severe Sepsis and Septic Shock Early Management Bundle; SIRS, systemic inflammatory response syndrome.
aTime zero organ dysfunction criteria for severe sepsis include: systolic blood pressure <90 mmHg or decrease by >40 mmHg or mean arterial blood pressure <65 mmHg; lactate >2.0 mmol/L; initiation of mechanical ventilation or noninvasive positive pressure ventilation; creatinine >2.0 mg/dL, or urine output <0.5 mL/kg/hour for 2 hours; total bilirubin >2 mg/dL; platelet count <100 000 × 109/L; international normalized ratio >1.5; or activated partial thromboplastin time >60 seconds.