3/21/2016

Points to Focus

Best IV Practices to
Prevent SEPSIS
Dr. Jayant R. Giri MD
Clinical Initiatives, Central and South Asia

Sepsis

Pathogenesis of CLABSIs & Biofilm

Risks with Short PIVCs

Clinical Practice Guidelines & INS Standards

Catheter Care Bundles

Randomized Clinical Trials

March 17 , 2016
Bandung, INDONESIA
th

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Sepsis

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Indwelling Medical Devices Sources Of HAIs & Sepsis

INDWELLING MEDICAL DEVICES

CENTRAL LINE / PIVCs, VENTILATOR,

URINARY CATHETER, SURGICAL IMPLANT

TREATMENT
WITH ANTIBIOTICS

SEPSIS
3

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PREVENTION
THROUGH CARE
BUNDLES

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http:/ / www.world-s eps is -day.org/?MET=SHOWCON TAIN ER&vPRIMN AVISELECT=3&vSEKNAVISELECT=3&vCONTAINERID=

Sepsis Causes

INDWELLING
MEDICAL DEVICE

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PROLONGED
PLACEMENT
DURATION

Advances in Microbial Biofilm Prevention on Indwelling

6
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MedicalDevices
with Emphasis on Us age of Acoustic Energy,Sensors 2009

IMPROPER
ASEPSIS

MICROBIAL
INFECTION &
BIOFILM
FORMATION

SEPSIS

of Becton, Dickinson and Company.

3/21/2016

Sepsis A Global Burden!

300,000

Sepsis Rising Trends!

5

Mortality incidence

250,000

200,000
150,000
100,000
50,000
0
HIV/AIDS

P rostate
Can cer

Brea st Can ce r

S eps is

http:/
/ www.world-s
eps isthe
-dayBD
.org/?MET=
SHOWCON
TAIN ER&vP
AVISELECT=3&vS
EKNAVISELECT=3&vCONTAINERID=
7
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rksRIMN
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AIN ER&vP
AVIS
ELECT=3&vS
EKNAVISELECT=3&vCONTAINERID=
8
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roperty
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Pathogenesis of CLABSIs

Risk Factors

CVCs can become contaminated with microorganisms via two major routes
INTRINSIC

Age:
CLABSIs are higher among
children, particularly neonates
& VLB (<750gms.)
In Adults burn & critical
care units

Underlying Diseases:
Hematological &
immunological deficiencies
Cardiovascular &
Gastrointestinal diseases

EXTRINSIC

Tenfold increase in risk in

ped. ICUs with multiple CVCs

Intraluminal

Multiple CVCs

Contaminated
INFUSATE

Extraluminal
SKIN
FLORA

Dwell time
Risk increases with CVC dwell
time

Parenteral Nutrition
Administration
Multi Lumens
Lack of MSB

Male Gender

Associated with increased risk

of CLABSIs

Almuneef
2016 et.
BD. al
BD, the

Hematogenous

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Whats a Biofilm?

BIOFILM

Contaminated
HANDS

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Biofilm Formation
Microbes attach to internal and external catheter surfaces

Bacteria organize themselves into a

cooperative community. This
bacterial community is held together
with biofilm.

It is a structured community of
microorganisms enclosed in a selfprotective matrix where they
cooperate to protect themselves
from a hostile environment

Resident flora deep in skin layers are not removed during

skin prep
Catheters dwelling < 10 days have more biofilm on external
surface.

Internal surfaces through all hub manipulation

Medication administration
Tubing and cap changes
Flushing procedures
Catheters dwelling more than 30 days have more biofilm on
internal surfaces.

Occurs on virtually all indwelling

VADs
- Biofilm taken from inside a needleless connector.
- Connectors changed every 7 days (Donlan, et.al, 2001)

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3/21/2016

Biofilm Detachment

Catheter Material

Catheter material can influence the development of BSIs

Some catheters have irregularities that can enhance the

adherence of certain microorganisms

Silicon elastomer catheter surfaces allow biofilm formation,

more readily than PU catheters

Some catheters are more thrombogenic than others, which is a

predisposition to colonization & infection

Biofilm dispersed in clumps remains resistant to host defenses and antimicrobials,

and may result in serious focal infections such as endocarditis
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www.erc.montana.edu

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13

PIVCs are failing around the globe

Peripheral Intra-Venous

43%

Catheters (PIVCs)

53%

51%
38%

26%

- An under-evaluated problem
42%

58% 27%
100%

43%

26%

54%

34%

Incidence from published PIV studies are not directly comparable since definitions &
study questions have varied, butwe do seem to have a problem!!

15

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PIVCs

34% of PIVs FAILED

Peripheral venous catheters (PIVC) are the most frequently

used invasive device in hospitals.

removal was:

PIVC Failure

Any complication that stops the PIVC being useful

Also called premature removal

26% OCCLUSION / INFILTRATION - 1512 PIVs

169/1512 also had phlebitis

Includes: I-POD
Infiltration or Infection
Phlebitis (most commonly pain)
Occlusion (cannot infuse fluids)
Dislodgement (accidental removal)
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Of 5907 PIVs (Lancet study) the main complication causing

6% ACCIDENTAL REMOVAL - 375 PIVs

7/375 also had phlebitis

5% PHLEBITIS - 273 PIVs

Total = 34% FAILED - 1,984 PIVs

1202/3283 patients: Rickard et al. 2012 Lancet.

* Wallis
MC.Rickard
CM.
Infection
Control
and
63 -68.
2016
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L ogo
and all other
trademarks
areHospital
property of Epidemiology
Becton, Dickinson 2014;35(1)
and Company.
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3/21/2016

Overview of mechanisms for

PVC - BSI

PVC BSI

PVC-associated bloodstream infection (PVC-BSI) or sepsis is

a far more serious adverse event of catheterization

The most likely mechanism of PVC-BSI is colonization of

the vascular catheter tract followed by biofilm
formation

Such colonization may occur during catheter insertion and

when manipulating the catheter for drug administration or
blood sampling

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19

20

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PVC - BSI

Although the rates of PVC - BSI are low, especially when

compared with central venous lines

A Systematic Review

Absolute PVC-BSI numbers may approach absolute central

of 200 Published Studies

line-associated infection (CLABSI) rates outside the ICU

21

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22

PIVC - BSIs

23

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Summary PIVCs - BSIs

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BD, theRN,BC,
BD L ogoCRNI;
and all other
tradema
rksInfusion
are propertyNursing
of Becton,2012
Dickinson and Company.
Lynn Hadaway,
Journal
of
24

3/21/2016

Organizations Recommending
Standards for IP&C for IV
Therapy

Clinical Practice Guidelines

25

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26

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INS
History
I N S located in Norwood MA, U S, is a national
nonprofit organization founded in 1973
I N S is setting the standard for dedicated
c linicians who s eek to provide excellent infusion
c are across all practice settings

INFUSION NURSES SOCIETY

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2016

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Goals of Infusion Therapy

Standards of Practice

INFUSION THERAPY
STANDARDS OF
PRACTICE

Without a standard there is no logical basis for making a decision or

taking action. - Joseph M. Juran
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3/21/2016

Infusion Therapy
Standards of Practice a view of ToC

ARE
INS - STANDARDS OF PRACTICE
ALIGNED TO GLOBAL GUIDELINES?

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Most relevant to
C DC
JC I
W HO
Va rious a ccre ditation standards

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JCI INICC CLABSI Monograph

references INS

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http://www.jointcommission.org/preventing_clabsi/. Accesed on August 12th 2012

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3/21/2016

Infusion Therapy
Standards of Practice!!
INS SOPs referenced by the worlds most adopted
guidelines
Thus, when it comes to infusion INS is the top most
authority

It helps achieve patients safety goals as required by

JCI
Well aligned to the infection prevention & control
goals of preventing CrBSIs

Will form a basis for sustained adoption of safety

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Sec tion Seven

Vascular A ccess Device (VA D)-Related
Complications

PIVC failure - burden

Phlebitis SOP #45 (S95)

Chemical p hleb itis

Infusates with d extrose >10% or hig h osmolarity (>900 mOsm/L)
Certain medications; such as p otassium chlorid e, amiod arone, and some
antibiotics
Particulates in the infusate

Too larg e a catheter for the vasculature with inadequate hemodilution

Skin antiseptic solution that is not fully dried and pulled into the vein during
catheter insertion

Mechanical p hleb itis

Vein wall irritation, which can come from too larg e a catheter for the vasculature,
catheter movement, insertion trauma, or catheter material and stiffness
Choose the smallest catheter for therapy, 20 or 22 gauge if possible; secure
catheter with stabilizing device; avoid areas of flexion, and stabilize joint as needed

Bacterial p hleb itis

Emergent vascular access device (VAD) insertions and p oor asep tic
techniques

200 million catheters estimated to be inserted

each year in the USA alone

If even 15% are needed for more than 3 days,

then a change to clinically required replacement

Prevent up to 6 million unnecessary intravenous

catheter insertions

save about 2 million hours of staff time, and up to

40

What are Care Bundles?

& Types of Care Bundles?

Catheter Care Bundles

Care bundles are groupings of best practices with respect to

a disease process that individually improve care, but when
applied together result in substantially greater
improvement
THE CLABSI BUNDLE
PREVENTION OF CENTRAL LINE ASSOCIATED BLLOD STREAM INFECTIONS

THE VAP BUNDLE

PREVENTION OF VENTILATOR ASSOCIATED PNEUMONIAS

THE CAUTI BUNDLE

PREVENTION OF CATHETER ASSOCIATED URINARY TRACT INFECTIONS

THE SSI BUNDLE

PREVENTION OF SURGICAL SITE INFECTIONS

41

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http://www.ihi.org/resources/Pages/Changes/ImplementtheCentralLineBundleaspx
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3/21/2016

CVC Insertion:

The Central Line Care Bundles

EDU CATION ,
TRAIN IN G

H AN D
H YG IEN E

ASEPTIC
TECH N IQU E

CVC
INSERTION
PREPARATION

CVC
IN SERTION

CVC
MAIN TEN AN CE

CVC AN D
SYSTEM
COMPON EN TS
REMOVAL

Us e of a CVC i nsertion bundle

INICC PICUs of 5 Countries
12

9
8
7
6
5
4
CLAB
3
2
1
0

10

7.7

6
CLAB
4
0

Bundle

Baseline

Strattegy: Bundle

BUNDLES
43

Bundle

Strategy: Bundle

Pronovos t, P., D. N eedham, et al. (2006). "An intervention to decrease

catheter-related bloods tream infections in the ICU ." The New England
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the BD2725-2732.
L ogo and all other trademarks are property
journal
of 2016
medicine
355(26):

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5.2

1.4
Baseline

TOOLS AN D
TECH N IQU ES

10.7

Ros enthal, V. D., B. Ramachandran, et al. (2012). "Impact of a multidimensional

infection control s trategy on central line-as s ociated bloodstream infection rates in
developing countries : findings of the International
N os ocomial Infection Control Cons ortium (IN ICC)." Infection 40(4): 415-423.

intens iveancare
units
of pediatric
Becton, Dickinson
d Compa
ny.of five

The Lancet 2012; 380: 1066-1074

Randomized Clinical Trials

45

Risk
(95% CI)

Phlebitis per
Patient

114 /1593
(7.2%)

114/1690
(6.7%)

RR 1.06
(0.83-1.36)

0.64

Phlebitis per
1000 days

13.08

13.11

HR 0.94
(0.73-1.23)

0.67

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Per 1000
PIV days

Clinical
n=1593

Routine
n=1690

HR
(95% CI)

All PIV failure

77
(n=670)

73
(n=636)

0.99
(0.89-1.11)

0.87

Infiltration

32
(n=279)

27
(n=235)

1.06
(0.89-1.27)

0.51

Occlusion

40
(n=344)

40
(n=344)

0.92
(0.79-1.07)

0.92

Accidental
removal

19
(n=166)

18
(n=159)

0.98
(0.79-1.23)

0.88

No difference in PIV failure

between study groups

Routine
n=1690

No difference in phlebitis rates

between study groups

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Clinical
n=1593

Per 1000 PIV

days

Clinical
n=1593

PIV-BSI

All-BSI

Routine
n=1690

HR
(95% CI)

0.46
(n=4)

0.1
(n=1)
1.03
(n=9)

0.46
(0.14-1.48)

0.19

Local infection

Colonisation

13.0

12.4

Mortality (%)

0.25%
(n=4)

0.24%
(n=4)

1.05
(0.32-3.68)
RR 1.06
(0.27-4.23)

NS
0.93

Infection was rare and not different

between study groups

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3/21/2016

PIVC failure - burden

200 million catheters estimated to be inserted

each year in the USA alone

If even 15% are needed for more than 3 days,

Prevent up to 6 million unnecessary intravenous

catheter insertions

save about 2 million hours of staff time, and up to

49

then a change to clinically required replacement

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Study Overview

Products Overview:
SS+SUF vs. 3WSC
Closed IV system

Objective:
To compare the clinical impact and cost-effectiveness of CLABSI
prevention
Study Design:

A Randomized controlled trial (RCT)

5 ICUs of 2 centers, 2 Cities in India;

Outcomes:

Clinical impact and cost effectiveness analysis

Patient Groups:

1,096 ICU adult patients those needed a central line

Ros enthal VD, U dwadia FE, Kumar S, et al. Clinical impact and cos t-effectivenes s of s plit-s eptum and s ingle-us e
prefilled flus hing device vs 3-way s topcock on central line-as s ociated bloods tream infection rates in India: a
randomiz ed clinical trial conducted by the International N os ocomial Infection Control Cons ortium (IN ICC). Am J Infect
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Control 2015;43:1040-5

4.7

4.5

6.00

CLABSI Rate (%)

CLABSI x 1000 CL-days

4
RR: 0.35
P value: 0.006

3.00
2.21

3.5
3

1.5

1
1.00
0.00
CLA BSIs per 1000 CLdays , n

A valve or tuning plug that

controls the flow of fluid from
a container through a tube.
Open to the air when the
cover is not in place

Single-use Prefilled Flushing Devices

(SUF)

Multiple use container (MUC)

A prefilled
single use vial
for IV lines
when drugs are
not compatible

A 100 to 500 ml
container as a
common source of
fluids

1. Establish standards

2. Increase compliance to SOPs & Bundles of Care

Infection & Infiltration
Phlebitis
Occlusion
Dislodgement
Costs

RR: 0.31
P value: 0.002

2.5

1.5

2.00

CLABSI Rate per 100 patients, %

5

6.40

4.00

Simple needleless
connector with a
pre-pierced septum
that can be of a
blunt cannula or
luer-lock design

Conclusion

CLABSI Rate per 1000 CL-days

5.00

Open IV system
Three-Way Stopcocks (3WSC)

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CLABSI Rate
7.00

Split Septums (SS)

0.5
0
SS+SUF gr oup

3WSC gr oup

2.21

6.40

CLA BSI r ate per 100

pat ient s , %

SS+SU F G ro up

3 W SC G r oup

1.5

4.7

3. Bundles are a combination of:

Practices
Technology

CLABSI incidence rate is significantly lower in SS + SUF group than in 3WSC + MUC group

Ros enthal VD, U dwadia FE, Kumar S, et al. Clinical impact and cos t-effectivenes s of s plit-s eptum and s ingle-us e prefilled flus hing
device vs 3-way s topcock on central line-as s ociated bloods tream infection rates in India: a randomiz ed clinical trial conducted by
2016 BD. BD, the BD L ogo and all other trademarks are property of Becton, Dickinson and Company.
the International N os ocomial Infection Control Cons ortium (IN ICC). Am J Infect Control 2015;43:1040-5

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3/21/2016

Successful Outcomes with Care

Bundles
Maintenance
Bundles
Insertion
Bundles

Terima Kasih!

Technology
& Training

Minimize
SEPSIS &
Costs
55

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10