Drug intervention trials in sepsis Armand R.J. Girbes
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1 Drug intervention trials in sepsis Armand R.J. Girbes Professor in Intensive Care Medicine Clinical Pharmacologist VU medical center Amsterdam, NL
2 Sepsis - definition
3 Sepsis Epidemiology cases per 100,000 per year 9% increase per year! 2% hospital admissions 9% severe sepsis & septic shock = 10% of all ICU admissions peak in 6th decade of life No 3 in death cause underestimated!!
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8 Epidemiology of sepsis in Germany Main points Prospective-observational observational cross sectional 1-day 1 point prevalence study 454 ICU s s in 310 stratified representative hospitals Screened patients: N = % sepsis 11% severe sepsis Hospital mortality of severe sepsis = 55% Estimated Incidence: cases per 100,000 per year Data from longitudinal survey in 371 patients: incidence 110 cases
9 Sepsis Epidemiology - Causes chest abdomen genitourinary system primary bloodstream 80% of all causes rate pneumonia/bacteraemia bacteraemia/multiple site infection
10 Main pathogens in sepsis
11 Increased knowledge of mechanism
12 Sepsis Key elements diffuse endovascular injury aberrant release of pro-inflammatory cytokines procoagulant response / dysregulated coagulation apoptosis
13 Drug intervention trials in (severe) Sepsis Since 1980s Drug intervention trials modify endotoxin release inhibition of proinflammatory cytokines > 80 trials
14 Phase III trials in severe sepsis Pattern Positive phase II studies No dose finding studies (Relative) large phase III studies Negative findings
15 Phase III trials in severe sepsis Modification of endotoxin release Failure Inhibition of proinflammatory cytokines Failure Inhibition of platelet-activating activating-factor inflammatory pathway Failure
16 Phase III trials in severe sepsis Explanation for failures Misconception & limitation of underlying models Targeting single steps is inappropriate Oversimplification Animal model incorrect [e.g. wrong animal; single exposure [e.g. wrong animal; single exposure i.o.. continuous] Difference in timing in experimental models Too late administration Inappropriate models E.g. infusion of endotoxin Inappropriate dose Dose finding studies in general lacking Insufficient attention to role of concomitant treatment
17 Phase III trials in severe sepsis Polderman & Girbes, Lancet 2004
18 Phase III trials in severe sepsis Natural anticoagulant proteins AT III Protein C Tissue Factor Pathway Inhibitor Levels decrease during sepsis Tempting target for intervention Highly promising preliminary results Only apc positive result
19 Phase III trials in severe sepsis
20 Phase III trials in severe sepsis
21 Activated protein C vs. placebo in phase III study on mortality and bleeding Mortality Severe bleeding rhapc 210/850 (24.7%) 30/850 (3.5%) Placebo 259/840 (30.8%) 17/840 (2%) RR 80.6% RR 175% RRR 19.4% RRR -75% ARR 6.1% ARR -1.5% NNT 16 NNT 66
22 PROWESS & ENHANCE 100 ENHANCE DrotA(a) EVAD DrotA(a) EVAD Placebo 90 Survival (%) 80 PROWESS DrotAA (24.7% mortality) 70 PROWESS Placebo (30.8% mortality) ENHANCE DrotAA (25.3% mortality) Days After the Start of the Infusion
23 APC long-term effect
24 Long-term effect
25 apc trial Problems Changed protocol halfway Inclusion criteria Change of drug carrier Possible interaction with heparin Effect ONLY in 2 nd part of the study Inclusion prematurely stopped (because of efficacy) Only one study; No confirmatory study done
26 Problems in apc trial Strata Total Therapy Died by Day 28 Original Amended rhapc Placebo rhapc Placebo P= P= (28) 109 (30) 108 (22) 150 (31)
27 apc in less severe sepsis
28 apc in less severe sepsis N=2613
29 Severe sepsis trial design Like in myocardial infarction? Like in cancer trials? Like in hypertension trials? Like in osteoporosis trials? ICU trials require different approach
30 ICU Mortality depends on ICU organization intensivist driven 24/24 and 7/7 presence nurse density [fte per ICU bed] size / volume - experience
31 Effect of ICU
32 Sepsis trials in the ICU Centers include only 1 or 2 patients No attention paid to concomitant treatment ICU organization different SMR (mortality corrected for severity of disease) antibiotics and infection timing correct? source control early goal directed therapy etc etc
33 Sepsis trials in the ICU
34 Sepsis trials in the ICU
35 Sepsis drug intervention trials in the ICU Ongoing trials Eritoran (TLR 4 Lipid A antagonist) Recombinant Human Antithrombin (+DIC) GR (protein-free phospholipid emulsion binding endotoxin TAK-242
36 Drug trials in sepsis CONCLUSIONS Sepsis is a complicated syndrome All drug intervention trials negative, but one Is the model appropriate? Do we jump to phase III too quickly Trial design RCT Patient inclusion criteria Source control YES or NO; antibiotics Participating ICU inclusion criteria missing
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