Meta-analyses, Guideline Development & Implementation

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Transcript Meta-analyses, Guideline Development & Implementation

Guidelines and Current Practices in the
ICU in 2013: Are There Still Gaps?
Rupinder Dhaliwal, RD
Manager , Research & Networking
Clinical Evaluation Research Unit
Queen’s University, Kingston, Canada
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Conflict of interest/Disclosures
Co-author of Canadian Clinical Practice Guidelines
 I have received speaker honoraria and/or I have been
paid from grants from the following companies:
–
–
–
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Nestlé
Fresenius Kabi
Baxter
Abbott
None for this project
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Learning Objectives
Become familiar with the updated recommendations from the
Canadian CPGs
Trophic feeds
GRVs
Enteral Fish oils
Probiotics
Parenteral glutamine
Parenteral Selenium
PN Type of Lipids
Supplemental PN
Review the current nutrition practices in ICUs around the
World (International Nutrition Survey 2013)
To identify areas in current practices that need to be improved
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Knowledge To Action Model
Identify the Problem
How are ICU pts around the
World being fed ?
International Nutrition Survey (INS) 2013
Purpose
illuminate gaps between current practice & guidelines
identify practice areas to target for change
History
started in Canada in 2001
5th International audit (2007, 2008, 2009, 2011 & 2013)
Methods
Observational, point prevalence study
Methods
• Each ICU enrolled 20 consecutive patients
• ICU LOS> 72 hrs
• vented within first 48 hrs
• Data abstracted from chart
•
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Hospital and ICU characteristics
Patient information
Baseline Nutrition Assessment
Daily Nutrition data
Patient outcomes
(e.g. mortality, length of stay)
• Benchmarking Report provided
• Best of the Best Competition if n ≥ 20 patients
www.criticalcarenutrition.com
Participation: INS 2013
202 ICUs
26 nations
4040 patients
37,872 days
Canada: 24
Europe &
Africa: 35
USA: 52
Colombia:6
Uruguay:4
Venezuela:2
Peru:1
Mexico: 1
Latin
America: 14
Turkey: 11
UK: 8
Ireland: 4
Norway: 4
Switzerland: 3
Italy: 1
Sweden: 1
Spain: 1
South Africa: 2
Asia: 41
Japan: 21
India: 9
Singapore: 5
Philippines:2
China: 2
Iran : 1
Thailand: 1
Australia &
New
Zealand: 36
ICU Characteristics
Characteristics
Total (n =202)
Hospital Type
Teaching
Non-teaching
Size of Hospital (beds)
Mean (Range)
ICU Structure
Open
Closed
Other
Size of ICU (beds)
Mean (Range)
Designated Medical Director
Presence of Dietitian(s)
170 (84.2%)
32( 15.8%)
581 (50-2500)
51 (25.2%)
148 (73.3%)
3 (1.5%)
17(4-86)
185 (91.6%)
164 (81.2%)
Patient Characteristics
Characteristics
n = 4040
Age (years)
Median [Q1,Q3]
63 [50-74]
BMI
Median [Q1, Q3]
25.7 [22.5 - 30]
Admission Category
Medical
2588 (64%)
Surgical: Elective
428 (10.6%)
Surgical: Emergency
1024 (25.3%)
Apache II Score
Presence of ARDS
Median [Q1, Q3]
22 [16-27]
365/4040 (9%)
Clinical Outcomes
Outcomes
n=4040
Length of Mechanical Ventilation (days)
Median [Q1, Q3]
6.6 [3.1, 13.6]
Median [Q1, Q3]
10 [5.8, 18.9]
Length of ICU Stay (days)
Length of Hospital Stay (days)
Median [Q1,Q3]
21 [10.8, 44.9.]
Patient Died (within 60 days)
Yes
991 (24.5%)
Knowledge To Action Model
Synthesizing Knowledge (evidence)
Canadian Nutrition Guidelines
JPEN 2003
 1980-2003
2005
2007
2009
2013
update
update
update
update
www.criticalcarenutrition.com
New Evidence
2009
2013
207 RCTs
275 RCTS
34 Topics
17
recommendations
45 Topics
22
recommendations
68 new RCTs across 27 topics!
Canadian CPGs 2013
Topic
2013 RCTs
Total RCTs
Fish Oils/Borage Oils
4
8
Probiotics
12
23
Combination EN + PN
3
8
PN Type of lipids
4
9
PN Glutamine
11
28
PN Selenium
7
18
Intentional Underfeeding: Trophic vs Full Feeds
2
Threshold of GRVs
2
2
Early Supplemental PN vs Late
1
1
PN + EN Glutamine
1
1
new topics
2
Available
online now
NCP Feb 2014
EN: Trophic Feeds
Effect of Trophic feeds on mortality
Canadian CPGs Internal Committee
2013 Recommendation






no effect on mortality or VAP
Inbetter
patients
with Acute
Injury, an initial
maybe
gastrointestinal
toleranceLung
but underfeeding
no safety concerns if trophic feeds for 5 days
strategy of trophic feeds for 5 days should
long term effects of this strategy (muscle mass, function, functional recovery)?
notBMIs,
be no
considered
patients age ~ 52 yrs, high
comorbidities: represent pt that would benefit?
recommendation based on values other than the treatment effect alone
INS 2013: Trophic Feeds*
8.4% all
patients
6.4% all
ARDS pts
* At initiation of EN, pts on EN prior to ICU excluded
Gastric Residual Volumes
2013 Recommendation
Canadian CPGs Internal Committee
2013 Recommendation
 no differences in clinical outcomes
There are insufficient data to make a recommendation for not
checking
nutritionalgastric
adequacy
improvement
was minimal
residual
volumes
or a specific gastric residual
 does not include difficult tovolume
feed pts threshold.
(MOF, surgical)
 vomiting associated with increased infection, length of stay and mortality
(Metheny
J Crit
2008)a gastric residual volume Reignier
Based
on 2Am
level
2 Care
studies,
of either2013
 opposing
risks
of higher GRVs
CCM is
2001,
McClave CCM
250
or 500views
mLsof(or
somewhere
in(Mentec
between)
acceptable
as2005)
a
 strategy
Montejo
2010:
hemodynamic
stability
patientsnutrition
unknown.
to optimize
delivery
of of
enteral
Not checking
gastric
residual volumes
was
associated
with: in critically ill
patients.
 increased rates of vomiting
 better nutritional adequacy
INS 2013: GRVs threshold
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INS 2013: EN interruptions
% pt days on EN
Need to explore protocols to
manage these interruptions
Enteral Fish Oils*
*Product enhanced with fish oils +borage oils +
antioxidants
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Enteral Fish Oils*
*Product enhanced with fish oils +borage oils + antioxidants
2009 Recommendation
Based on 5 studies, we recommend the use of
enteral formula with fish oils, borage oils, and
antioxidants in patients with ALI/ARDS
New RCTs = 4
Rice 2011 (bolus)
Grau-Carmona 2011
Thiella 2011
Elamin 2012
EN Fish oils with new RCTs
2013
2013 Recommendation
Canadian CPGs Internal Committee
Fish Oils/borage oil: Downgraded recommendation to
“should
bestudy
considered”
 mortality disappears
when bolus
is include (statistical heterogeneity)
 effect on mortality is significant when bolus study excluded
 infections (2 RCTs): no effect
 reduction in ICU LOS still significant (heterogeneity)
 concerns of control group, negative results of large studies
Fish Oils alone: insufficient data
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INS 2013: Use of Enteral Fish Oils
Formula (enteral)
Patients receiving these
formulas*
Fish oil enriched formula
(all patients)
10.0% (0.0%-100%)
Fish oil enriched formula
(in ARDS patients)
20.2% (0.0%-100%)
* Of those patients on EN or EN+PN
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Probiotics
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Probiotics
2009 Recommendation
There are insufficient data to make a recommendation on
the use of Prebiotics/Probiotics/Synbiotics in critically ill
patients
New RCTs = 12
(only probiotics)
Schlotterer 1987
Kecskes 2003
Lu 2004
Li 2007
Klarin 2008
Knight 2009
Barraud 2010
Morrow 2010
Frohmader 2010
Ferrie 2011
Sharma 2011
Tan 2011
Petrof et al
Critical Care
2012
Probiotics with 12 new RCTs
Canadian CPGs Internal Committee
2013
Recommendation
Probiotics
 stronger
signal
for reduction in infections
(2009: no reduction)
 higher quality studies do NOT show a reduction in infections
 trend towards a reduction in VAP (p=0.06)
 still trend
towards
ICUconsidered”
mortality
Upgrade
toreduction
“shouldinbe
 no risk with use (exception of Saccharomyces boulardii)
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INS 2013: Use of Probiotics
Formula (enteral)
Supplemental Probiotics
1
Patients receiving these formulas
(of all patients)
4.9% (0.0%-100%)
Glutamine supplementation?
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PN Glutamine
2009 Recommendation
Based on 17 studies, when parenteral nutrition is prescribed to critically ill
patients, parenteral supplementation with glutamine, where available, is
strongly recommended. There are insufficient data to generate
recommendations for intravenous glutamine in critically ill patients receiving
enteral nutrition
Tian 2006
Zhang 2007
Yang 2008
Ozgultekin 2008
Eroglu 2009
Perez Barcena 2010
New RCTs = 11
Grau 2011
Andrews 2011
Wernerman 2011
Cekman 2011
Zeigler 2013 (in press)
+ Heyland 2013 (EN + PN)
PN GLN with 11 new RCTs

less effect on overall mortality & infections, now a trend
 hospital mortality and ICU LOS significant reduction (heterogeneity)
 large scale multicenter randomized trials of IV glutamine have failed to
demonstrate a convincing positive effect (Andrews, Wernerman,
Ziegler)
 safety concerns from REDOXS can not be ignored
2013 Recommendation:
PN Glutamine
Downgraded to “should be considered”
CAUTION: do not use PN glutamine in patients with shock and MOF
PN + EN Glutamine
 REDOXS: largest multicentre trial
 patients with at least 2 organ failures
 increase in mortality across all time points
2013 Recommendation:
strongly recommend that high dose combined
parenteral and enteral glutamine supplementation NOT
be used in critically ill patients with multi-organ failure
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EN Glutamine
2009 Recommendation
Based on 2 level 1 and 7 level 2 studies, enteral glutamine should
be considered in burn and trauma patients. There are insufficient
data to support the routine use of enteral glutamine in other critically
ill patients
New RCTs = 0
Heyland 2013 GLN EN + PN
2013 Recommendation:
……In addition, we strongly
recommend that any glutamine
NOT be used in critically ill
patients with shock and multiorgan failure
INS 2013: Use of Glutamine
Glutamine Supplementation
Patients receiving
supplementation
EN patients
Enteral glutamine supplementation*
5.3% (0.0% -100%)
IV/PN glutamine supplementation
2.0 % (0.0% - 36.4%)
PN patients
Enteral glutamine supplementation*
8.8 % (0.0% - 100%)
IV/PN glutamine supplementation
9.2% (0.0% - 33.3%)
Burn patients
Any glutamine supplementation
4.9% (0.0 %-33.3%)
Trauma patients
Any glutamine supplementation
14.1% (9.9%-100%)
In patients with Shock or MOF
?
* Over and beyond standard formula
Parenteral Selenium
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Parenteral Selenium
2009 Recommendation:
There are insufficient data to make a recommendation
regarding IV/PN selenium supplementation, alone or in
combination with other antioxidants, in critically ill patients
New RCTs = 7
Lindner 2004
El Attar 2009
Gonzalez 2009
Andrews 2011
Manzanares 2011
Valenta 2011
Heyland 2013
removed Schneider 2011
PN Selenium with new RCTs
PN selenium
 no effect on mortality (was a trend p =0.13)
 reduction in infections, p =0.04 (was no effect)
 no effect on LOS (same)
2013 Recommendation:
Upgraded to “should be considered”
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INS 2013: Use of PN Se
Selenium Supplementation
1
Patients receiving
supplementation
EN patients
IV/PN supplementation
1.7% (0.0% - 63.2 %)
PN patients
IV/PN supplementation
6.4% (0.0% - 100%)
Any IV/PN Selenium supplementation
1.7% (0.0 %- 65%)
Any Enteral Selenium supplementation
0.3 % (0.0%-66.7%)
PN Type of Lipids
2009 Recommendation
There are insufficient data to make a recommendation on the
type of lipids to be used in critically ill patients receiving
parenteral nutrition.
New RCTs* =4
Wang 2009
Barbosa 2010
Umpierrez 2012
Pontes-Arruda 2012
X include studies that had no soybean
oil in control
*omega-6 fatty acid load (or soybean oil sparing strategy) vs. soybean emulsion
2013 Recommendation
Canadian
CPGs Internal Committee
(Upgrade)
 new signals for
•reduction in mortality (p =0.20)
IV lipids
reduce
the heterogeneity
load of omega-6
•ICU
LOS (pthat
= 0.13),
statistical
presentfatty
•durationoil
of ventilation
(p=0.09)
acids/soybean
emulsions
should be considered. There
are insufficient data on type of soybean reducing lipids
 no effect on infections (p=0.58) 2009 same
 no direct comparisons so not clear on what type of omega-6 sparing strategy
INS 2013: Type of PN lipids
% of patient days on PN
EN + PN
Lancet 2012
Combined EN + PN
used indirect calorimetry
No difference mortality
reduced infections day 4-28
+ Abrishami 2010
+ Chen 2011
No change from 2009
we recommend that PN not be started
not be started at the same time as EN.
Insufficient evidence in those who are
not tolerating EN (case by case)
NEJM 2011
Early Supplemental PN vs. Late
large multicentre
early PN: worse infections, LOS
early PN: no diff mortality
high glucose loading
low risk patients
Strongly recommend that early PN & high IV
glucose not be used in low risk, short ICU stay
Insufficient evidence in those who are not
tolerating EN (case by case)
INS 2013: EN + PN
% ICU days
EN + PN = 4.5%
INS 2013: use of Early vs Late PN
Timing of PN start in patients on EN (n =189 ICUs)
PN start from ICU
admit
5.1 days
INS 2013: Overall Adequacy Calories
Prescribed 1741 [1500-1997] Kcals
24.9 [20.2-26.7] Kcal/kg/day
Average across all days: 62% (0-185%)
INS 2013: Overall Adequacy Protein
Prescribed 82 [68-100] gms
1.1 [1.0-1.3] gms/kg/day
Average across all days: 58% (0-165%)
Summary
• Several gaps exist in current nutrition practices when
compared to the latest recommendations
Gastric Residual Volumes (interruptions)
Probiotics
PN Glutamine (in shock, MOF)
PN Selenium
• Significant underfeeding still exists in ICUs around the World
• Barriers to adoption needs to be evaluated
• Need to explore innovative strategies to improve nutrition
delivery in the ICU
Acknowledgements
Canadian Clinical Practice Guidelines Internal Committee
and
Margot Lemieux
Project Assistance
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Jesse Gadon
Electronic Data System
Miao Wang
Data Analyses
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