The results of a multi-center trial from the UK, the ProMISe trial, were just released and it confirms what two prior studies (i.e., ProCESS and ARISE) have already shown; there does not appear to be any difference in mortality when septic patients are treated with a strategy of early-goal directed therapy as compared to usual care.
Patients were included in the ProMISe trial if they were in septic shock and were then randomized to either the EGDT group (630 patients) or the usual care group (630 patients); a total of 1,260.
The primary end-point was all cause mortality at 90 days and there was no difference shown in the primary outcome. There were no differences found in the measured secondary outcomes (e.g., serious adverse events)
This trial adds to the evidence that septic patients may not benefit from protocolized (i.e., EGDT) care versus usual care. One explaination why, is that our “usual care” in 2015 has significantly changed since the introduction of EGDT in 2001.