Difference between revisions of "EBQ:ProCESS Trial"

(Exclusion Criteria)
Line 37: Line 37:
  
 
==Exclusion Criteria==
 
==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/mm<sup>2</sup>
 +
*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
  
 
==Interventions==  
 
==Interventions==  

Revision as of 00:50, 20 March 2014

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

Inclusion Criteria

  • Emergency Department Patients with suspected sepsis
  • ≥18 years old
  • Two Systemic Inflammatory Response Syndrome criteria
  • Refractory Hypotension OR
  • Serum Lactate ≥ 4 mmol/L


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

Interventions

Outcome

Primary Outcomes

Secondary Outcomes

Subgroup analysis

Criticisms & Further Discussion

Funding

Sources

Supplemental Publication