CURRENT GUIDELINES FOR SEPSIS MANAGEMENT
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1 HELLENIC SEPSIS STUDY GROUP CURRENT GUIDELINES FOR SEPSIS MANAGEMENT Evangelos J. Giamarellos-Bourboulis, MD, PhD Associate Professor of Medicine 4 th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Greece Guest Professor, Center for Sepsis Control and Care, Jena University Hospital, Germany
2 CONFLICT OF INTEREST DISCLOSURE None for this presentation Honoraria (paid to the University of Athens): AbbVie USA, Astellas Greece, Biotest Germany, Brahms GmbH, InflaRx GmbH Germany, MSD Greece, Novartis Greece SA, Pfizer Greece Consultant: Astellas Greece, InflaRx GmbH, Germany, Roche CH, Xbiotech USA Independent educational grants: AbbVie USA, Abbott CH, Axis Shield, UK, Inflammatix USA, InflaRx GmbH Germany, Xbiotech USA European Grants: FrameWork 7 program HemoSpec, Horizon2020 Marie-Curie Grant European Sepsis Academy.
3 Rhodes A, et al. Crit Care Med 2017; 45: 486 PILLARS OF SEPSIS MANAGEMENT Sepsis management Haemodynamic therapy Source control Antimicrobials ADJUNCTIVE THERAPY
4 % patients EARLY START OF ANTIMICROBIALS: MAIN GOAL (Kumar A, et al. Crit Care Med 2006; 34: 1589) Time (hours) from start of hypotension
5 SEPSIS-3 DEFINITION (Singer M, et al. JAMA 2016; 315: 801) A life-threatening organ dysfunction caused by a dysregulated host response to infection.
6 SEQUENTIAL ORGAN FAILURE ASSESSMENT SOFA score po 2 /FiO <400 <300 <200 <100 Platelets (x10 3 mm 3 ) 150 <150 <100 <50 <20 Bilirubin (mg/dl) < Cardiovascular MAP 70mmHg MAP < 70mmHg <5* 1** >1** Glasgow Coma Scale <6 Creatinine (mg/dl) (or urine/day) < (<500) 5.0 (<200) *μg/kg/min of dopamine **μg/kg/min of noerpinephrine
7 INFECTION SUSPICION qsofa (quick SOFA) 2 qsofa Altered mental status 22 breaths/minute Systolic blood pressure<100 mmηg EVALUATE ORGAN DYSFUNCTION SOFA 2 admitted in the ER or increase from the baseline SEPSIS SEPTIC SHOCK Despite fluid resuscitation Mean arterial pressure <65mmHg Lactate 2 mmol/l NEED for vasopressors ER: emergency department
8 % patients THE OTHER READ-OUT (Kumar A, et al. Crit Care Med 2006; 34: 1589) 100 Survival Cumulative effective antimicrobial therapy Time (hours) from start of hypotension
9 RESISTANCE PATTERNS: ER ADMISSION (Koupetori M, et al. BMC Infect Dis 2014; 14: 272) *p< 0.05 between the two periods
10 EPIDEMIOLOGY AS A GUIDING TOOL (Koupetori M, et al. BMC Infect Dis 2014; 14: 272) OR 95%CI p APACHE II> History of COPD Pigtail ureter catheterization Chronic hemodialysis Intake of antibiotics 3 months Residence in long-term care facility <0.0001
11 A MULTI-CENTER SIMULATION: THE HELLENIC SEPSIS STUDY GROUP : 32 CENTERS : 3 CENTERS : 2 CENTERS : 1 CENTER
12 EMPIRICAL ANTIMICROBIALS OUTSIDE THE ICU WITH SOFA 7 3 rd gen. cephalosporin +/- metronidazole Piperacillin/tazobactam Carbapanem EMPIRICAL ANTIMICROBIALS OUTSIDE THE ICU WITH SOFA >8 Piperacillin/tazobactam +/- colistin +/- glycopeptide Carbapanem +/- colistin +/- glycopeptide
13 Serum concentration Serum concentration Serum concentration INCREASE T>MIC FOR B-LACTAMS (MacVane SH, et al. Int J Antimicrob Agents 2014; 43: 105) INCREASE THE DOSE 1g q8h 2g q8h PROLONG INFUSION 1g 0.5H 2g 3H 25% MIC 25% MIC Time (hours) 1g q8h (0.5H) 2g q8h (3H) Time (hours) 50% BOTH!!! MIC Time (hours)
14 HOW ABOUT COLISTIN? (Plachouras D, et al. Antimicrob Agents Chemother 2009; 53: 3430) Colistin methasulfonate is an inactive pro-drug Hydrolyzed into active colistin A and colistin B MIC breakpoint 2μg/ml ( 4μg/ml for P.aeruginosa) 3MU (240mg) q8h in 18 critically ill patients Serum concentrations after 1 st dose Serum concentrations after 4 th dose (24h)
15 NEED FOR INITIAL LOADING DOSE OF 9MU (Mohamed AF, et al. Antimicrob Agents Chemother 2012; 56: 4241)
16 UPDATED DOSING REGIMENS TO ACHIEVE PLASMA COLISTIN C ss 2 mg/l (Nation RL, et al. Clin Infect Dis 2017; 64: 565) 9 million units loading dose to all patients CrCl (ml/min) Daily dose (millions divided into two) to < to < to < to < to < to < to < to < to <
17 OPTIONS FOR ADJUNCTIVE THERAPIES IN SEVERE INFECTIONS: SSC 2016 INTERVENTION COMMENT Low-dose hydrocortisone replacement in septic shock Only if hemodynamic stability cannot be achieved (weak recommendation) Treatment with IV Igs AGAINST preparations of only IgGs Weak recommendation of IgM-enriched preparations Rhodes A, et al. Crit Care Med 2017; 45: 486
18 THE FRENCH STUDY (JAMA 2002; 288: 862) (START hydrocortisone replacement 3-8 h from onset of hypotension) CORTICUS TRIAL (N Engl J Med 2008; 358: 111 (START hydrocortisone replacement <72 h from onset of hypotension)
19 THE APPROACH OF THE HELLENIC SEPSIS STUDY GROUP (1) (Katsenos C, et al. Crit Care Med 2014; 42: 1651) Late: >9hrs from vasopressors (n= 124) Early: <9hrs from vasopressors (n= 46) log-rank: p: 0.018
20 THE APPROACH OF THE HELLENIC SEPSIS STUDY GROUP (2) (Katsenos C, et al. Crit Care Med 2014; 42: 1651) Late: >9hrs from vasopressors (n= 124) Early: <9hrs from vasopressors (n= 46) log-rank: p:
21 Giamarellos-Bourboulis EJ, et al. Crit Care 2013; 17: R247 SEVERE SEPSIS TO SEPTIC SHOCK: 28-DAY MORTALITY AUC SURVIVORS : mg.day/dl AUC NON-SURVIVORS : mg.day/dl p: 0.037
22 ARE THERE ALARMING Ig LEVELS? IMMUNOSCORING (Bermejo-Martín JF, et al. J Intern Med 2014; 276: 404) IgG1 >300 mg/dl IgM >35 mg/dl IgA >150mg/dl IgG1 300 mg/dl IgM 35 mg/dl IgA 150mg/dl
23 RR: relative risk META-ANALYSIS OF CLINICAL TRIALS (Kreymann KG, et al. Crit Care Med 2007; 35: 2677) IgM-enriched IV polyvalent (IgGAM) (12% IgM, 12% IgA, 76% IgG) RR: % risk for death IgG IV polyvalent RR: % risk for death
24 TOTAL NUMBER OF PATIENTS WITH CLINICAL DATA IN THE REGISTRY= 5,143 Step 1: ICU-ACQUIRED INFECTIONS= 1,299 COMPARATORS (from the same hospitals)= 1,077 Excluded from matching (n=2 neutropenia) IgGAM= 232 (ALL Severe sepsis/shock) Step 2: Severe sepsis/shock= 622 Step 3: MDR Gram-negative= 213 Step 4: Case control matching 1:1 matching for sepsis severity 1:1 matching for appropriateness of empirical antimicrobial treatment Fuzzy matching for source of infection Fuzzy matching for CCI EXCLUDED= 132 Lack of microbiology= 72 Incomplete data= 33 Catheter-related infections= 20 Neutropenia= 4 Gram-positive infections= 2 Primary immunodeficiency= 1 ANALYZED= 100 MDR: multidrug-resistant ANALYZED= 100 Giamarellos-Bourboulis EJ, et al. Clin Microbiol Infect 2016; 22: 499
25 Giamarellos-Bourboulis EJ, et al. Clin Microbiol Infect 2016; 22: 499 MATCHED BASELINE DEMOGRAPHICS Comparators (n= 100) IgGAM (n= 100) Age 54.2 ± ± Severe sepsis/shock 14/86 14/ APACHE II score 20.7 ± ± SOFA score 8.9 ± ± Appropriateness of empirically prescribed antimicrobials 51/49 51/ Primary bacteremia Ventilator-associated pneumonia Ventilator-associated pneumonia + bacteremia Intrabdominal + bacteremia 2 2 Charlson s comorbidity index 2.86 ± ± p
26 PRIMARY ENDPOINT: 28-DAY MORTALITY (Giamarellos-Bourboulis EJ, et al. Clin Microbiol Infect 2016; 22: 499) Mortality= 39% OR death under IgGAM Mortality= 58% 0.37 (95%CIs: ) log-rank: 6.88 p: 0.009
27 SECONDARY ENDPOINT 2: EFFECT ON TIME TO BREAKTHROUGH BACTEREMIA* (Giamarellos-Bourboulis EJ, et al. Clin Microbiol Infect 2016; 22: 499) 50%= 4 days 50%= 10 days log-rank: *A new episode of bloodstream infection in a patient having sterile blood cultures for 72 hours. p<
28 SURVIVING SEPSIS CAMPAIGN 2016 (Rhodes A, et al. Crit Care Med 2017; 45: 486) Addition of a macrolide for patients with septic shock after Streptococcus pneumoniae bacteremia Weak recommendation, low quality of evidence
29 META-ANALYSIS OF 16 OBSERVATIONAL STUDIES (Nie W, et al. J Antimicrob Chemother 2014; 69: 1441)
30 PROSPECTIVE, RANDOMIZED APPROACH (Garin N, et al. JAMA Intern Med 2014; 174: 1894) Community-acquired pneumonia Cefuroxime or amoxycillin/clavulanate Clarithromycin 500mg bid iv or po Monotherapy β-lactam / β-lactam + clarithromycin combination Primary endpoint: patients not reaching clinical stability on day 7 Powered for non-inferiority
31 % of patients BENEFITS OF ADDING CLARITHROMYCIN (Garin N, et al. JAMA Intern Med 2014; 174: 1894) Monotherapy (n= 291) Combination (n= 289) p: % 33.6% p: % 3.1% Instability Day 7 30-day readmission
32 200 patients with VAP + Sepsis/ Severe Sepsis/Septic Shock (ACCP/SCCM 1992) 100 iv PLACEBO + ANTIBIOTICS** 100 iv CLARITHROMYCIN* + ANTIBIOTICS** *1000mg iv daily within one hour x 3 days **Standard of Care VAP: ventilator-associated pneumonia (NCT ) Giamarellos-Bourboulis EJ, et al. Clin Infect Dis 2008; 46; 1157
33 % resolved cases EFFECT ON RESOLUTION OF VAP 80% 60% 40% p: Placebo Clarithromycin 20% 50%: 10 days 50%: 15.5 days 0% Days (NCT ) Giamarellos-Bourboulis EJ, et al. Clin Infect Dis 2008; 46; 1157
34 FINAL OUTCOME!!! (Tsaganos T, et al. Antimicrob Agents Chemother 2016; 60: 3640) 57% log-rank: % MORTALITY DAYS (%) p: p: Placebo Clarithromycin
35 REVERSAL OF IMMUNOPARALYSIS (Spyridaki A, et al. Antimicrob Agents Chemother 2012; 56: 3819) p: p: p: 0.024
36 HOW TO DEAL WITH IN 2018? Early broad-spectrum antimicrobials Decision based on epidemiology and SOFA scoring Intense work-up for hemodynamic stability (fluids + vasopressors) Adjunctive approches
37
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