Reducing the Reporting Burden in the Regulatory Environment,
Reducing the Burden of Severe Sepsis and Infections in Indian … Divatia -Reducing the... ·...
Transcript of Reducing the Burden of Severe Sepsis and Infections in Indian … Divatia -Reducing the... ·...
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Reducing the Burden of Severe Sepsis and Infections
in Indian ICUs
J.V. Divatia
Professor & Head Department of Anaesthesia, Critical Care & Pain
Tata Memorial Hospital Mumbai
India
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Infections in the ICU • Sepsis and multiple organ failure is the
commonest cause of death in ICU’s • ICU patients are 5-10 times more prone
to infection • Increased nosocomial infections • Infections with resistant strains
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ICU
Community Hospital
• Widespread use of oral QN and Ceph
• Free availability of OTC antibiotics
• Self-medication by patients
• Availability of cheap generics of variable potency and quality
• Spread by crowding and poor sanitary conditions.
• Lack of hospital-wide infection control or antibiotic policies
• Extensive empirical use of cephalosporins in hospitals and ICUs
• Prolonged use of antimicrobial prophylaxis in surgical patients
• Failure to restrict privileges to prescribe major antibiotics
Absence of national agency to survey and report on nosocomial inffections Absence of effective national or statewide antimicrobial policy
• Predominance of open ICUs • Failure to implement or adhere to
infection control protocols • Prolonged use of broad-spectrum
antibiotics • Inadequate staffing, especially
nurses
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Angus DC, et al. JAMA 2000;284:2762-70. Angus DC, et al. Crit Care Med 2001;29:1303-10.
Severe Sepsis is Increasing in Incidence
Severe Sepsis Cases US Population
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Title: This is the footer Date: 13th September 2012 Slide no: 5
Sepsis is a Medical Emergency
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Severe Sepsis Stroke Breast Cancer Lung Cancer
IncidenceMortality
* Calculated data based on information compiled from the American Heart Association, American Cancer Society, National Center for Health Statistics and the US Census Bureau (1995-1999) † Severe sepsis mortality rates range from 28%-50% (79/100,000 to 141/100,000 population).
Severe Sepsis Incidence and Mortality
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Title: This is the footer Date: 13th September 2012 Slide no: 7
Sepsis : A neglected but common entity
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Title: This is the footer Date: 13th September 2012 Slide no: 8
Reducing the Global Burden of Sepsis
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EPIC-II INDIA
Total Patients 13796 533
Total ICUs 1265 39
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EPIC II India
• 39 ICUs, 533 patients from India • Infected 213 (40%) • ICU Mortality 13.4% • Hospital Mortality 17.2% • Central and South America had the highest
infection rate (60%) • Africa had the lowest (46%)
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Microorganisms Microorganisms (%) EPIC-II India
Positive isolates 69.8 63.4
Gram-positive 46.8 23
Gram-negative 62.2 77.8
Anaerobes 4.5 0.7
Fungi 19.0 8.1
Viral/Parasitic 0.7 5.1
Other bacteria 1.5 3
Other organisms 3.9 2.2
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Types of organisms Microorganisms % EPIC-II All India Gram-positive
Staphylococcus aureus 20.5 10.4 MRSA 10.2 3.7 S. epidermidis 10.8 0.7 S. pneumoniae 4.1 1.5 Enterococcus 11.0 5.9 Others 6.4 5.9
Gram-negative E. coli 16.0 21.5 Enterobacter 7.0 1.5 Klebsiella spp 12.7 23.7 Pseudomonas spp 19.0 33.3 Acinetobacter spp 8.8 16.3
*P < 0.05 vs Western India
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Types of organisms
Microorganisms % EPIC-II All India Others 17.0 6.7
Anaerobes 4.5 0.7 Other bacteria 1.5 3 Fungi
Candida 17.0 6.7 Aspergillus 1.4 2.2 Others 1.0 0.7
Parasites 0.7 1.5 Other organisms 3.9 5.9
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International Nosocomial Infection Control Consortium
• Non Profit Organization • Collects and analyses infection related data from the developing countries and prepares a report which is sent to the ICU • Publishes data in high quality journals
MISSION: An International scientific community that works interactively through a network aiming at reducing healthcare-associated infections in developing countries
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HCAIs – Indian Data • 12 ICUs of 7 Indian cities • Prospective surveillance from July 2004 to
March 2007 • 10 835 patients hospitalized for 52 518 days • 476 HCAIs, 4.4% or 9.06 HCAIs/1000 ICU-days • CVC-BSI rate 7.92/ 1000 catheter-days
– Excess mortality 4% • VAP rate10.46 / 1000 ventilator-days
– Excess mortality 19% • CAUTI rate 1.41 /1000 catheter-days
– Excess mortality 11.6%
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Antibiotic Resistance • Overall 87.5% of all Staphylococcus
aureus HCAIs were caused by MRSA Enterobacteriaceae resistance • 71.4% resistant to ceftriaxone • 26.1% to piperacillin-tazobactam Pseudomonas aeruginosa resistance • 28.6% resistant to ciprofloxacin • 64.9% to ceftazidime • 42.0% to imipenem
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Antimicrobial Resistance at TMH Pseudomonas sp
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Antimicrobial Resistance at TMH E. Coli & Klebsiella sp
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Indian Intensive Care Case Mix and Practice Patterns Study
July 14, 2010; October 13, 2010; January 12, 2011, April 13, 2011
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INDICAPS Study Design
• Multicenter, All-India observational, one-day prevalence study, performed on four separate days
• Inclusion criteria • All patients present in the ICU on the second
Wednesdays of July and October 2010, January and April 2011 – July 14, 2010 – October 13, 2010 – January 12, 2011 – April 13, 2011
• Data of all patients in the ICU for the 24 hours starting 0800 am to 0800 am next day.
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Severe Sepsis or Septic Shock
Characteristic Patients Age APACHE II SOFA ICU Mortality
Severe Sepsis / Septic Shock
1144 (28.3%)
53.8 ± 17.7
20.0 ± 8.4 **
5.9 ± 4.3**
42.1% **
No severe Sepsis
2894 (71.7%)
54.2 ± 17.7
16.9 ± 7.9
2.6 ± 2.9
17.6%
• Severe Sepsis / Septic Shock was diagnosed in 1144 patients (28.3%) – Males 725 (63.4%), Females 419 (36.6%)
• Infection developed in ICU in 235 patients (20.5%)
** : p=0.000
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Patients with Tropical Infections vs. Others with Severe Sepsis / Septic Shock
Tropical Infection N = 231 (20.2%)
No Tropical Infection N=913 (79.8%)
Age 46.2 ± 17.9 55.7 ±17.2**
APACHE II 16.4 ± 7.5 20.9 ± 8.3 **
Acute Physiology Score
14.0 ± 7.0 16.1 ± 7.2**
SOFA 6.3 ± 4.3 5.8 ± 4.3
ICU Mortality 71 (30.7%) 411 (45.0%)**
** : p=0.000
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Microorganisms Identified
Gm Neg 69%
Gm Pos 17 %
Fungi 8 %
Virus 1 %
Mycobact 2 %
Micro-organisms • Cultures sent in 909 patients (79.5%)
• Positive in 368 / 909 patients (40.5%)
• 576 organisms identified
• Polymicrobial cultures in 140 / 368 positive cultures (38%)
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Major Microorganisms (n=576)
Gram Negatives N =400 (69.4%)
Pseudomonas aeruginosa
92 (23%)
Pseudomonas spp 13 (3.2%)
Acinetobacter spp 89 (22.3%)
Klebsiella spp 84 (21%)
E. Coli 76 (19%)
Gram Positives N = 98 (17%)
MRSA 22 (22.4%)
MSSA 17 (17.3%)
Enterococcus (Vancomycin sensitive)
14 (14.3%)
MR-CNS 13 (13.3%)
MS-CNS 9 (9.2%)
Strep. pneumoniae
7 (7.1%) Fungi n=44 Candida albicans 27 (61.4%) Candida non-albicans 15 (34.1%)
MR: Methicillin resistant; MS: methicillin sensitive SA: staph. aureus; CNS: coagulase negative staph.
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Antibiotic use
No. of antibiotics given
• 1032 (90.2%) patients were receiving antibiotics on the study day
• Patients received a median of 2.0 (IQR 1,3) or mean of 1.9 ± 1.1 antibiotics
9,8
27,4
34,6
20,5
7,8
05
10152025303540
0 1 2 3 4No. of Antibiotics
% patients
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Antibiotics Used Antifungal
13% Aminoglycoside
8% AntiTB
1 % Antimalarial 5%
Antiviral 3%
Aztreonam 2%
Carbapenems 30%
Cephalosporins 27%
Glycopeptide 15%
Linezolid 6%
Macrolides 5%
Other 20%
Penicillins 24%
Quinolones 14%
Tigecycline 4%
Colistin / Polymixin B
9%
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Major Antibiotics used • Antifungals (154)
– Fluconazole 56%, Caspofungin13%, Amphotericin B 10% • Cephalosporins (309)
– Ceftriaxone 34%, Cefoperazone-sulbactam 28% • Penicillins (272)
– Piperacillin-tazobactam 72% • Carbapenems (346)
– Meropenem 66%, Imipenem 25% • Glycopeptides (177)
– Teicoplanin 70%, Vancomycin 30% • Levofloxacin (111 / 155), 72% of Quinolones • Colistin / Polymixin B (108)
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Management of Severe Sepsis
• Antibiotics for primary infection • Percutaneous or surgical drainage • High-quality intensive care • Modulate inflammatory response • Prevent secondary infections
– Exogenous & endogenous
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Antibiotic Therapy in Sepsis • Start early, after obtaining samples for C/S • Intravenous • Adequate doses • Broad-spectrum • Initially empirical • Specific therapy after C/S • De-escalate whenever possible
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Consequences of Overdiagnosis of Sepsis
• Inappropriate use of antibiotics • Increases costs • Risk of adverse drug reactions • Selects for resistant microbial flora
– increase morbidity and mortality • Incorrect diagnosis can engender a false
sense of security – Distract a clinician from finding and treating
the true cause of a patient’s clinical deterioration
JAMA 2007; 297:1583-93
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Broad-Spectrum Antibiotics Creating problems
• Kill harmful organisms, and several other non-pathogenic ones as well
• Negative culture reports • Overgrowth of Cl. difficile • Overgrowth of fungi • Selects out resistant organisms • Induces resistance
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Antimicrobial Stewardship Strategies
• Education • Clinical guidelines • Antimicrobial restriction • Preprescription approval • Prospective audit and feedback
– Postprescription review • Computer-based decision support • Antibiotic cycling?
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Optimising antimicrobial therapy
• Avoid prolonged Prophylactic Antibiotics • Combination therapy • Dose and route • PK / PD principles • De-escalation • Duration of therapy • Biomarker guided therapy : procalcitonin • Patenteral to oral conversion
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AUC
Cmax (Peak)
MIC
T >MIC
Time (Hours)
Conc
entr
atio
n
Cmax / MIC
Time dependent • B-lactams • Carbapenems • Linezolid • Erythromycin • Lincosamines
Concentration dependent • Aminoglycosides • Metronidazole • Daptomycin
Conc and Time Dependent • Fluoroquinolones • Glycopeptides • Tigecycline
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Barriers to De-escalation • Negative blood / other cultures.
– 40-60% of blood cultures may be negative • Positive cultures : colonization or infection?
– Contaminants – Errors in collection of samples – Quantitative instead of Non quantitative cultures
• No clinical improvement • Clincal improvement
• Why change a winning team?
• Role of biomarkers • Advanced molecular diagnostic
techniques
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Bundles of Care • Concept of “bundles” developed by IHI
• Help health care providers more reliably deliver the best possible care for patients undergoing particular treatments with inherent risks
• Structured way of improving the processes of care and patient outcomes
• A small, straightforward set of evidence-based practices — generally three to five — that, when performed collectively and reliably, have been proven to improve patient outcomes
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Sepsis Resuscitation Bundle Goals in the first 6 hours
1. Serum lactate measured 2. Blood cultures obtained prior to antibiotics 3. From the time of presentation, broad-spectrum antibiotics administered
within 1 hour In the event of hypotension and/or lactate >4 mmol/L 4. Deliver an initial minimum of 20 ml/kg of crystalloid (or colloid
equivalent*) 5. Vasopressors for hypotension not responding to initial fluid
resuscitation to maintain MAP ≥65 mm Hg 6. Achieve CVP of 8 mm Hg 7. Achieve ScvO2 of ≥ 70%
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Sepsis Management Bundle Goals over 24 hours
• Low-dose steroids administered for refractory septic shock not responding to fluids and vasopressor therapy
• Glucose control maintained ≥ lower limit of normal, but < 180 mg/dl
• Inspiratory plateau pressures maintained < 30 cm H2O for mechanically ventilated patients
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Management of Sepsis in Indian ICUs Indian Data from the MOSAICS Study
Management of Sepsis in Asia’s Intensive Care Units
India Co-ordinator : JV Divatia BMJ 2011;342:d3245
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MOSAICS Study Prospective, observational non-interventional
study • 1285 patients recruited, 16 countries, 148 ICUs
• All consecutive patients with severe sepsis in July 2009 • Excluded patients
– < 21yrs – Transferred from another hospital or from another ICU – Previously admitted to the ICU for severe sepsis
• Primary Outcome – Compliance with the 6-hour and 24-hour bundles
• Secondary Outcome – All-cause in-hospital mortality
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MOSAICS Study
Asia India No. Of ICUs 150 17
No. of Patients 1285 162
APACHE II 22.8 ± 8.7 21.9 ± 8.4
Hospital mortality 44.9% 38.3%
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Overall Bundle Compliance India
0102030405060708090
100
Resus Bundle ManagementBundle
Mx Bundlewithout aPC
Both (withoutaPC)
6,8 8 13 2,5
% Compliance
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Compliance with Sepsis Bundles Asia
8.5
1
6.87.5
18
11.4
2.72.6
4.9
8
4.23.1
2.4 2.1
8.5
13.713
10.8
14.8
11.810.9
0
2
4
6
8
10
12
14
16
18
20
China Hong Kong India Malaysia Singapore South Korea
Others
6-hr bundle24-hr bundle24-hr bundle less aPC
Com
plia
nce
(%)
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INICC - Process Surveillence
• Hand Hygeine • Care to prevent Nosocomial Pneumonia • Vascular Catheter Care • Urinary Catheter Care
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Care to Prevent Nosocomial Pneumonia
• Elevation of the Head of the Bed (30-45
degrees)
• Tubings / Water traps free of fluid and
secretions
• Absent air leak around cuff
• Smooth enteric nutrition
• Aseptic Aspiration technique
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Care to prevent CLABSI
• Date of Catheter Insertion • Correct condition of dressing • Sterile Dressings for peripheral lines • Use needleless intravascular catheter
access systems avoid stopcocks. • Closed catheter access systems should be
preferred to open systems.
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Process Surveillance Forms – Vascular Catheter Care
• Correct condition of dressing - well coated - clean - no fluid collection • Date of Catheter Insertion
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Process Surveillance Forms – Urinary Catheter Care
• Catheter over thigh • Level of the urine bag below level of the bladder • Urine bag should not have floor contact
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Effectiveness of a multidimensional approach for prevention of VAP in adult ICUs from 14 developing countries of 4
continents: INICC findings • 55,507 patients in 44 ICUs in 38 hospitals • Before and after study • Intervention:
– bundle of infection-control interventions – Education – outcome surveillance – process surveillance – feedback of VAP rates – performance feedback of infection-control practices.
Crit Care Med 2012
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INICC Multidimensional aproach to prevent VAP Results
Phase 1 VAP rate • 22.0 per 1,000 mechanical ventilator days Phase 2 VAP Rate • 17.2 per 1,000 mechanical ventilator days
• 55.83% reduction in the rate of VAP after
the intervention Crit Care Med 2012
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Research Opportunities Diagnosis of Sepsis
Empirical Antibiotics
Optimal Dosing
De-escalation
Differentiate non-infectious conditions: Biomarkers (procalcitonin)
• Rapid accurate diagnosis incl fungi, viruses • Rapid culture, • Molecular / PCR, microarrays, other • Identify resistant patterns
• ESBL +ve, carabapenemase, MBL, MRSA, VRE,
• New drugs!
• Therapeutic drug monitroing • Point of care tests • Rapid drug assays
• Diagnosis of absence of infection • Biomarkers
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Research Opportunities • Develop effective strategies for communication,
dissemination and implementation of guidelines • Develop simple effective strategies to prevent
nosocomial infections – Bundles – INICC strategy
• Nationwide surveillance of antimicrobial therapy, AMR
• Nationwide Process surveillance – Hand hygiene
• Monitoring and feedback
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