EBQ:ProCESS Trial

incomplete Journal Club Article

The ProCESS Investigators. "A Randomized Trial of Protocol-Based Care for Early Septic Shock". NEJM. 2014. online first(online):11.
PubMed Full text PDF

Clinical Question

In patients with severe sepsis in the Emergency Department dose protocol-based resuscitation improve outcomes

Conclusion

No mortality or morbidity benefit was found with protocol-based resuscitation compared to bedside care in patients with severe sepsis.

Major Points

This multicenter randomized trial assigned patients 1341 patients to protocol EGDT (Early Goal Directed Therapy), protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions or usual care which was not standardized. The data was analyzed with intention to treat to determine in protocolized treatment of sepsis had a mortality benefit as was shown in the original Rivers Trial. No significant 60 or 90 day mortality benefit was found to the protocol therapy and greater hospital resources such as ICU admissions were found in the protocol based groups.

Study Design

• Multicenter Randomized trial of 1241 patients (439 in protocol-based EGDT, 446 in protocol based standard therapy, and 456 in the usual-care group)
• The same physician led team implemented the EGDT and protocol based standard therapies
• The resuscitation guidelines were published in the supplemental document
• 31 Academic Hospitals
• Intention to treat statistical analysis
• Primary Outcome: All cause in hospital mortality at 60 days

Inclusion Criteria

• Emergency Department Patients with suspected sepsis within 12 hour of ED arrival and 2 hours within detection of septic shock
• ≥18 years old
• Two SIRS Criteria
• Refractory Hypotension((SBP <90 mmHg or required vasopressors to maintain SBP≥90 mmHg after an IV fluid challenge) ) OR
• Serum Lactate ≥ 4 mmol/L

Participating Hospitals were required to have:

1. >40,000 annual ED visits
2. Use lactate as a screening measure for shock
3. Not have a routine resuscitation protocol for septic shock
4. Follow the Surviving Sepsis Campaign guidelines for non resuscitation aspects of care
5. Not use ScvO₂ catheters routinely

Exclusion Criteria

• Primary CVA
• Acute Coronary Syndrome
• Acute Pulmonary Edema
• Status Asthmaticus
• Major Cardiac Arrhythmia
• Acute GI Hemmorrhage
• Seizure
• Drug Overdose
• Burn or Trauma
• Immediate surgical requirement
• CD4 count < 50/mm²
• Advanced directive restricting protocol
• Central Venous Catheter contraindication
• Likelihood of refusing a blood transfusion
• Resuscitation deemed futile
• Participation in another interventional study
• Pregnancy
• Transfer to outside hospital

Sources

Supplemental Publication