Sepsis & septic shock · Protocolised early resuscitation
A randomized trial of protocol-based care for early septic shock
| Design | Multicentre randomised controlled trial with three arms |
|---|---|
| Treatment | Protocol-based early goal-directed therapy, or protocol-based standard therapy |
| Control | Usual care |
| Population | 1341 patients with septic shock diagnosed in the emergency department |
| Follow-up | 90 days |
| Primary endpoint | 60-day in-hospital mortality |
| Result | 439 patients received protocol-based EGDT, 446 protocol-based standard therapy and 456 usual care. Resuscitation strategies differed significantly in central venous monitoring and use of intravenous fluids, vasoactive drugs and transfusion, but outcomes did not. |
| Secondary endpoints | 90-day mortality, one-year mortality, organ support |
In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes.
The trial authors, in the published abstract
The first of three trials to overturn Rivers EGDT. Its three-arm design is the informative part: even stripping the protocol back to fluids and pressors without central venous oxygen monitoring changed nothing.
Yealy DM, Kellum JA, Huang DT, et al. A randomized trial of protocol-based care for early septic shock. N Engl J Med 2014 May 1;370(18):1683-93.