Use of surrogate inflammatory markers in the diagnosis & monitoring of patients with severe sepsis
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1 Thursday 11 th June 2015 Use of surrogate inflammatory markers in the diagnosis & monitoring of patients with severe sepsis Dr Duncan Wyncoll Guy s & St Thomas NHS Trust, London Conflicts of Interest In the last 3 years I have acted as consultant, or received honoraria/research grants from: Astellas, Biovo, Covidien, Iskus Health, J&J, Pfizer, Sage & Vygon
2 Current status severe sepsis
3 Biomarkers in Critical Care Markers of Inflammation C-reactive Protein Procalcitonin Markers of Homeostasis Renal: creatinine, urea, electrolytes Endocrine: TSH, T3, T4, Cortisol Haematology: CD4 Liver: Albumin Markers of Cellular Integrity Heart: CK-MB, troponin, LDH, BNP Liver: AST, ALT, GT Muscle: Myoglobin Blood: D-dimer, C3, C4 etc Markers of Infection [TNF, IL-6] [Procalcitonin] [Protein C] Not much real change in the last decade
4 Molecular medicines & targeted care Personalized medicine Proactive medicine: Disease prediction & prevention Right disease Right subtype Right drug Right patient Right dose Right duration Diagnostic Proteomics Discovery Proteomics Genome-disease correlation Less empirical, Removal of non-responders Reduce toxicity, Improved outcomes & Resource utilisation Risk mitigation Lifestyle Treatment
5 Definitions of an ideal biomarker Specific Sensitive Predictive Robust Bridges preclinical trials Non-invasive/accessible/rapid & low cost
6 Types of Biomarkers Indicator of normal biologic process, pathology, or response to therapeutic intervention Type 0: disease markers correlate longitudinally with clinical indices Type 1: drug effect markers & correlate with mechanism of action Type 2: used as surrogate end-point; drug efficacy markers & correlate with clinical benefit Clin Pharmacol Ther 2001; 69: 89-95
7 What do I want a biomarker to help with? Prognosis & risk? Low priority Diagnosis in shock (i.e. is it septic shock?) Possibly Infection in a colonised/inflammatory pt? Would definitely help in critically ill patients Tailoring therapy Monitoring response: could be useful Antibiotic course length: could be very useful
8 What do I want a biomarker to help with? Prognosis & risk? Low priority Diagnosis in shock (i.e. is it septic shock?) Possibly Infection in a colonised/inflammatory pt? Would definitely help in critically ill patients Tailoring therapy Monitoring response: could be useful Antibiotic course length: could be very useful
9 Biomarkers a review sepsis & biomarker >3,500 references & >180 biomarkers Cytokines, chemokines, cell markers, cell receptors, coagulation biomarkers, vascular damage surrogates, vasodilatation, biomarkers of organ dysfunction, acute phase proteins, etc, etc Mainly used for prognosis; very few for diagnosis Pierrakos C & Vincent JL. Crit Care 2010; 14: R151
10 Biomarkers which determine severity of sepsis? CRP WCC VAS Single values vs. Pneumonia T 0 C Copeptin Pro-ADM Severity Index Overlap +++ Pro-ANP PCT Christ-Crain M & Muller B. Eur Respir J 2007; 30:
11 Observational study of PCT in ICU patients with pneumonia Bloos F et al. Crit Care 2011; 15: R88
12 What do I want a biomarker to help with? Prognosis & risk? Low priority Diagnosis in shock (i.e. is it septic shock?) Possibly Infection in a colonised/inflammatory pt? Would definitely help in critically ill patients Tailoring therapy Monitoring response: could be useful Antibiotic course length: could be very useful
13 Surviving Sepsis In patients with SEVERE SEPSIS using the Sepsis Resuscitation Bundle saves lives Measure the LACTATE level (ABG) Take CULTURES before antibiotic administration Aseptic BC technique FLUID CHALLENGE if hypotensive or lactate>2mmol/l Administer ANTIBIOTICS within 1 hours Always follow the Trust antibiotic guideline & Infection team advice Prescribe 1st dose as once only & inform nurse for urgent admin Document the antibiotic indication & the review/stop date
14 Am J Respir Crit Care Med 2013; 188: 77-82
15 GSTT severe sepsis screening tool My patient is unwell Could they have severe sepsis? How do I tell? Most patients with severe sepsis score 2 SIRS: Tachycardia Fever or hypothermia Tachypnoea Abnormal WBC or CRP Yes, now what? Is there a good explanation other than infection? Can t exclude infection Assess for organ dysfunction: Hypotension Lactate > 2mmol/l Oliguria < 0.5ml/kg/hr Acute confusion CXR infiltrates + hypoxia Low platelets/abn clotting
16 Procalcitonin as a diagnostic marker for sepsis: a systematic review & meta-analysis PCT is a helpful biomarker for early diagnosis of sepsis in critically ill patients BUT it cannot be recommended as a single definitive test Wacker C et al. Lancet Infect Dis 2013; 13:
17 Biomarker combinations to diagnose infection: a prospective study 151 Adults with 2 SIRS, admitted to medical emergency dept 96 bacterial 16 viral 5 parasitic Linear model Kofoed K et al. Crit Care 2007; 11: R38
18 Prospective, multicenter derivation of a biomarker panel to assess risk of OD, shock & death in severe sepsis patients Shapiro N et al. Crit Care Med 2009; 37:
19 What do I want a biomarker to help with? Prognosis & risk? Low priority Diagnosis in shock (i.e. is it septic shock?) Possibly Infection in a colonised/inflammatory pt? Would definitely help in critically ill patients Tailoring therapy Monitoring response: could be useful Antibiotic course length: could be very useful
20 Case example 78 year old lady admitted to ICU with infected leg ulcers, AKI & GI bleed. - Transfused, fluids vasopressors & antibiotics 10 days into ICU admission - New fever, moderate PS ventilation (40% oxygen), moderate yellow secretions, pulse 109/min SR, BP 134/48, WCC 20, CRP 68 - CXR: bilateral infiltrates
21 CXR
22 Case example More tests? or more antibiotics now? or wait?
23 Case example More tests? or more antibiotics now? or wait? What if her CRP was 90 the day previously?
24 Case example More tests? or more antibiotics now? or wait? What if her CRP was 90 the day previously? What if her CRP was 40 the day previously? (i.e. dynamic changes )
25 Case example More tests? or more antibiotics now? or wait? What if her CRP was 90 the day previously? What if her CRP was 40 the day previously? (i.e. dynamic changes ) Would measuring her PCT help?
26 Daily monitoring of biomarkers of sepsis in complicated ICU patients: can it support treatment decisions? PCT CRP Iapichino G et al. Minerva Anesthesiol 2010; 76:
27 What do I want a biomarker to help with? Prognosis & risk? Low priority Diagnosis in shock (i.e. is it septic shock?) Possibly Infection in a colonised/inflammatory pt? Would definitely help in critically ill patients Tailoring therapy Monitoring response: could be useful Antibiotic course length: could be very useful
28 CRP as a marker of VAP resolution Fast response Slow response No response Biphasic response Povoa P et al. Eur Resp J 2005; 25:
29 CRP as a marker of VAP resolution Fast response Slow response No response Biphasic response Survivors Non-survivors Povoa P et al. Eur Resp J 2005; 25:
30 PCT kinetics Charles PE et al. Crit Care 2009; 13: R38
31 What do I want a biomarker to help with? Prognosis & risk? Low priority Diagnosis in shock (i.e. is it septic shock?) Possibly Infection in a colonised/inflammatory pt? Would definitely help in critically ill patients Tailoring therapy Monitoring response: could be useful Antibiotic course length: could be very useful
32 The PRORATA Trial Bouadma L et al. Lancet 2010; 375:
33 The PRORATA Trial Bouadma L et al. Lancet 2010; 375:
34 The PRORATA Trial Bouadma L et al. Lancet 2010; 375:
35 The PRORATA Trial 23% fewer AB s in PCT group Bouadma L et al. Lancet 2010; 375:
36 PCT Guided Antibiotics 12 PCT Guided Control 10 8 Days of AB s Bouadma Stolz Hochreiter Schroeder Nobre Kopterides P et al. Crit Care Med 2010; 38:
37 A word of caution Similar survival, but increased & more prolonged organ failure The biomarker & antibiotic protocol are linked Both have to be optimally defined Jensen JU et al. Crit Care Med 2011; 39:
38 Conclusions Need to be much clearer about what question we want a biomarker to answer Biomarkers to help recognise those with severe sepsis PCT might be able to help Might a panel be better? Biomarkers might help in early recognition of treatment failure or inadequacy
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