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
- have patients in the control group been exposed to the intervention?