Sepsis Multicast 3/5

In show #3 we discuss PROCESS/PROMISE/ARISE. The 3 new trials that shook up the sepsis in 2014. We followed that with some blood utilization discussion and review of the TRISS trial.
  • Does protocolized care compare to usual care in Sepsis? 
  • Done over 7 years in 31 different hospitals; total of 1341 patients
  • 3 arms: EGDT, usual care, and protocol based 6 hour standard therapy arm
  • Each arm got 30 cc/kg before randomization
  • Primary Endpoint was 60 day mortality which saw no difference in mortality (18-21%)
  • 93% of EGDT patients got CVL's vs 57% in other groups
  • Dobutamine use 8% in EGDT compared to 1% in other two groups
  • Not a large amount of total fluid difference in the 3 arms
  • Blood transfusion high in EGDT arm of PROCESS (14% vs 7-8%); however this did not approach the 64% seen in the original Rivers trial
  • 88% adherence to Rivers protocol in the EGDT arm of PROCESS
 
PROMISE - & - ARISE
  • Neither trial had the 3rd protocolized arm that PROCESS had 
  • PROMISE
    • UK: 56 hospitals, 1260 patients
    • used central lines capable of continuous scvo2 in EGDT arm
    • returned to standard of care after 6 hours
    • Scvo2 was not permitted at all in the usual care arm, all other decision making was made by treating clinician
    • All cause mortality at 90 days was 29% in both groups
    • central line insertion rates in both groups very similar to PROCESS
  • ARISE
    • 51 hospitals and over 1600 patients in Australia/New Zealand
    • Results and Trial design similar to PROMISE
    • All cause 90 day mortality 18.6% vs 18.8%
 
  • Nearly 1000 septic shock patients in 32 ICU's weretransfused to either Hgb targets of 7 or 9
    • Original Rivers trial was 10
  • No difference in mortality between the two groups: 45% and 43% respectively 
  • 99% of patients in the liberal arm were transfused!
  • Only one patient experienced an adverse event related to blood transfusion in over 4000 study related transfusions
  • Didn't specifically use Rivers protocol, transfusions were not tied to Scvo2's
 
 
Comparing mortality rates in general between new trials and Rivers 
  • Are patient populations different?
  • Has Sepsis care improved? 
  • Concept of Contamination
    • have patients in the control group been exposed to the intervention?
      • EGDT has been widely used and adopted; ingrained in hospital culture
 
Jeremy AmayoComment