Early Goal Directed Therapy in 2015: What Did the Big Trials Teach us?
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1 Early Goal Directed Therapy in 2015: What Did the Big Trials Teach us? Mitchell M. Levy MD, FCCM Professor of Medicine Chief, Division of Pulmonary, Sleep, and Critical Care Warren Alpert Medical School of Brown University Providence, RI
2 Disclosure Financial: None Intellectual: Lots
3 N Engl J Med 2001;345: PRCT, single academic (Detroit) center 6 hours in ED Inclusion 2/4 signs and sx Suspected or confirmed infection Persistent hypotension cc/kg over 30 min SBP < 90 mm hg Lactate 4 mmol/l
4 N Engl J Med 2001;345: EGDT: TLC, 500 cc crystalloid Q30 min to CVP 8-12 mm hg Vasopressors for MAP < 65 mm hg ScvO 2 > 70% Control: RBCs to hct 30, then dobutamine to ScvO 2 > 70% CVP, but not ScvO 2
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8 PRCT, 31 academic medical centers in U.S. Adhere to Surviving Sepsis Campaign guidelines for non-resuscitation measures No routine resuscitation protocol
9 Inclusion Criteria 2 or more signs and sxs of inflammation Suspected or confirmed infection Evidence of refractory hypotension or hypoperfusion Initially: 20cc/kg over 30 minutes 2010: 1000cc over 30 minutes Randomize within 2 hrs after last criteria met Within 12 hours of arrival in ED
10 3 arms: Traditional EGDT protocol Provided by a study team Protocol-based standard therapy Same team as EGDT Usual-care group Managed by local team No ScvO 2 monitoring permitted
11 Screening, Randomization, and Follow-up. The ProCESS Investigators. N Engl J Med 2014;370:
12 The ProCESS Investigators. N Engl J Med 2014;370:
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14 Cumulative Mortality. Results: No difference in 60 and 90 day mortality Mortality rate (control) 18% The ProCESS Investigators. N Engl J Med 2014;370:
15 PRCT, 51 hospitals Australia, New Zealand, Finland, Hong Kong, Ireland Tertiary and nontertiary Urban and rural No resuscitation protocols
16 Inclusion Criteria 2 or more signs and sxs of inflammation Suspected or confirmed infection Evidence of refractory hypotension or hypoperfusion After 1000 cc bolus fluids in 60 minutes SBP < 90mm hg or MAP < 65mm hg Lactate 4 mmol/l Randomize within 2 hrs after last criteria met
17 Intervention: Traditional EGDT protocol Provided by a study team Unclear whether MDs worked in ED on other shifts Usual-care group Managed by local team No ScvO 2 monitoring permitted
18 ARISE NEJM Oct 2014
19 ARISE NEJM Oct 2014
20 ARISE NEJM Oct 2014
21 1260 patients 56 sites (29% teaching) EGDT vs. Usual Care Inclusion: Within 6 hours of presentation At least 1 liter of fluid within 60 minutes Lactate 4 mmol/l
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26 Comparison of 4 Trials N Mortality power calc BP Lactate Fluids BEFORE Enrolment Median time to randomize Rivers (Mar Mar 2000) % Not reported cc/kg 59 min 50 ProCESS (Mar May 2013) 1341 Initial: 30-46% Adjusted after 1st IA 55% 59% Unknown At least: 20cc/kg or 1000 cc min ARISE (Oct April 2014) % hosp 38% 90 day 70% 46% 2500 cc 35 cc/kg 165 min ProMISe Feb July % 90- day 55% 65% 2000cc 150 min
27 Comparison of 4 Trials: Results Volume EGDT vs. pbs vs. Control Vasopressors RBCs dobutamine Rivers 4981± ±2438 P< % 30.3% 64.1% 18.5% P< % 0.8% P<0.001 ProCESS P < % 52.2% 44.1% P = % 8.3% 7.5% P= % 1.1% 0.9% P <0.001) ARISE 1964± ±1401 P < % 57.8% 13.6% 7.0% 15.4% 2.6% ProMISe 2000 ( )1784 ( ) /
28 Concerns about ProCESS, ARISE, ARISE ProMISe Low rates of chronic illness/co-morbidity Short ICU LOS Who is this population?.5 pts per month Contamination? ProCESS 1351 randomized 1192 excluded for logistics 8 patients per center per year Same team for 2 protocol arms
29 So, What have we learned and Where are we now?
30 EGDT 4 trials Conclusions 1 single center, 3 large RCTs Different populations, different time periods Most recent trials: pts less ill 18% mortality?? No longer evidence to mandate central lines for all pts with severe sepsis and septic shock Usual Care Timely antibiotics, 3-5 liters of fluids
31 IF: So.Where are we? Timely antibiotics 30cc/kg fluids in first few hours Then: TLC for CVP and ScvO 2 monitoring not necessary Or use monitoring of your choice Unless pt is hypotensive and then need central line for pressors No adverse events with EGDT Harm not demonstrated
32 Does this mean we should go back to the ear of do whatever you want? Given the amount of fluids given prior to randomization in both trials, usual care appears to now include aggressive, early fluid resuscitation...this reflects the impact of Rivers and SSC. If this is usual care, then perhaps it is not longer necessary to mandate specific protocols for resuscitation.
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