EBQ:ProMISe Trial

incomplete Journal Club Article

Mouncey PR, Osborn TM, Power GS, et al. "Trial of Early, Goal-Directed Resuscitation for Septic Shock". NEJM. 2015. 14(372):1301-1311.
PubMed Full text

Clinical Question

Is there a different between EGDT versus “usual care” in 90-day mortality?

Conclusion

Using EGDT did not lead to an improved outcome

Population

56 hospitals in the UK

Inclusion Criteria

• ≥18 years of age
• Within 6 hours of presenting to ED
• Known or presumed infection
• 2 or more SIRS criteria
• Refractory hypotension (<90 SBP or <65 MAP after 1L IVF trial) or hyperlactatemia (≥4.0)

Exclusion Criteria

• CVA
• ACS
• Cardiac dysrhythmia
• Acute pulmonary edema
• GI bleed
• Seizure
• Drug overdose
• Burn or trauma
• Immediate surgery needed
• CD4 count <50
• Advance directive that restricts either protocol
• Contraindication to interventions including refusal of blood transfusions
• Pregnant
• Transfer patient

Interventions

• Radomization within 2 hours after meeting criteria

Group 1 – EGDT (n=623)

• Airway/breathing
• Central line with oximetric port
• Sedation, analgesia, and/or paralysis
• IVF per CVP
• Vasoactive agents per MAPs
• Transfusion and inotrope agents per ScvO2
• Reassess

Group 2 – Usual Care (n=620)

• Airway/Breathing
• 2 large bore IVs (or central line if not achieved)
• Sedation, analgesia, and/or paralysis
• Resuscitate with 2L IVF
• IVF and vasopressors per MAPs
• Reassess