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Nutrition & Rehabilitation Investigator’s Consortium Clinical Evaluation Research Unit
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Transcript of Nutrition & Rehabilitation Investigator’s Consortium Clinical Evaluation Research Unit
Nutrition & Rehabilitation Investigator’s ConsortiumClinical Evaluation Research UnitQueen’s University, Kingston General Hospital
Rupinder Dhaliwal, RD
Conflicts of Interest
I have received speaker honoraria or been paid from grants from the following companies:– Nestlé Canada
– Fresenius Kabi AG
– Baxter
– Abbott Laboratories
Objectives
• Describe rationale for the novel components of the PEP uP protocol
Enhanced Protein-Energy Provision via the Enteral Route in Critically Ill Patients:
• Review results of cluster trial using PEP UP Protocol
• Describe strategies to effectively implement this protocol in the ICU
1 2 3 4 5 6 7 8 9 10 11 120
20
40
60
80
100
120
Mean of All Sites Best Performing Site Worst Performing Site
ICU Day
% re
ceiv
ed/p
resc
ribed
Current Practice in ICUs in 2011
n =211 ICUs, mean intake 56% prescribed calories
Heyland et al INS 2011 unpublished data
Optimal Amount of Calories for Critically Ill Patients: Depends on how you slice the cake!
Heyland DK, et al. Crit Care Med. 2011;39(12):2619-26.
Optimal amount =
80-85%
Association Between 12-day Caloric Adequacy
and 60-day Hospital Mortality
Failure Rate
Heyland et al Unpublished observations Results of 2011 International Nutrition Survey (INS)
% high risk patients who failed to meet minimal quality targets (80% overall energy adequacy)
75.6 78.1
91.2
75.1
87.0
69.8
79.9
A shift in the feeding paradigm is needed!
Can we do better?
PEP UP Protocol: components
Early enteral nutritionGoal rate feeding in stable patientsTrophic feeds Feeding unstable patientsMotility agentsHigher gastric residual volumesProtein supplementsSemi-elemental formulaMonitor nutritional adequacy
Early EN (within 24-48 Hours of Admission) Is Recommended!
Optimal amount of protein and calories for critically ill patients?
Initial Efficacy and Tolerability of Early EN with Immediate or Gradual Introduction in Intubated Patients
Desachy A, et al. Intensive Care Med. 2008;34(6):1054-9.
N = 100 ptsmechanically ventilated pts(not in shock) to immediate goal rate vs gradual ramp up
“Trophic Feeds”
Progressive atrophy of villous height and crypt depth in absence of EN.
Leads to increased permeability and decreased IgA** secretion.
Can be preserved by a minimum of 10-15% of goal calories.
Observational study of 66 critically ill patients suggests TPN†
+ trophic feeds associated with reduced infection and mortality compared to TPN alone1. A = No EN; B = 100% EN
1Marik. Crit Care & Shock. 2002;5:1-10;Ohta K, et al. Am J Surg. 2003;185(1):79-85.
Just say noto NPO
Rice TW, et al. JAMA. 2012;307(8):795-803.
Initial Tropic vs. Full EN in Patients with Acute Lung Injury
The EDEN randomized trial
Trophic vs. Full EN in Critically Ill Patients with Acute Respiratory Failure
Despite no differences in clinical outcomes……….“Survivors who received initial full-energy EN were more likely to be discharged home with or without help as compared to a rehabilitation facility (68.3% for the full-energy group vs. 51.3% for the trophic group; p = .04).”
Rice TW, et al. Crit Care Med. 2011;39(5):967-74.
The EDEN randomized trial
Resuscitation is the priority
No sense in feeding someone dying of progressive circulatory failure
However, if resuscitated yet remaining on vasopressors:
What about feeding the hypotensive patient?
Safety and efficacy of EN??
Feeding the hypotensive patient?
Khalid I, et al. Am J Crit Care. 2010;19(3):261-8.
Prospectively collected multi-institutional ICU database of 1,174 patients who required mechanical ventilation for more than two days and were on vasopressor agents to support blood pressure.
The beneficial effect of early feeding is more evident in
the sickest patients, i.e., those on multiple
vasopressor agents
Pro-motility Agents
“Based on 1 level 1 study and 5 level 2 studies, in critically ill patients who experience feed intolerance (high gastric residuals, emesis), we recommend the use of a pro-motility agent”.
Conclusion: 1) Motility agents have no effect on mortality or
infectious complications in critically ill patients
2) Motility agents may be associated with an increase in gastric emptying, a reduction in feeding intolerance and a greater caloric intake in critically ill patients
2009 Canadian CPGs www.criticalcarenutrition.com
It’s Not Just About Calories...
So in order to minimize this, we order: Protein supplement Beneprotein® 14 grams mixed
in 120 mls sterile water administered BID via NG
Loss of lean muscle mass
Inadequate protein intake
Immune dysfunction
Weak prolonged mechanical ventilation
113 select ICU patients with sepsis or burns
On average, receiving 1,900 kcal/day and 84 grams of protein
No significant relationship with energy intake but…
Allingstrup MJ, et al. Clin Nutr. 2012;31(4):462-8.
Begin 24 hour volume-based feeds. After initial tube placement confirmed, start Peptamen® 1.5. Total volume to receive in 24 hours =<write in 24 target volume>. Determine initial rate as per Volume Based Feeding Schedule. Monitor gastric residual volumes as per Adult Gastric Flow Chart and Volume Based Feeding Schedule. OR Begin Peptamen® 1.5 at 10 ml/h after initial tube placement confirmed. Reassess ability to transition to 24 hour volume-based feeds next day. {Intended for patient who is hemodynamically unstable (on high dose or escalating doses of vasopressors, or inadequately resuscitated) or not suitable for high volume EN (ruptured AAA, upper intestinal anastomosis, or impending intubation)}OR
NPO. Please write in reason: __________________ ______. (only if contraindication to EN present: bowel perforation, bowel obstruction, proximal high output fistula. Recent operation and high NG* output not a contraindication to EN.) Reassess ability to transition to 24 hour volume-based feeds next day.
Stable patients should be able to tolerate goal rate We use a concentrated
solution to maximize calories per ml
Doctors need to justify why they are keeping
patients NPO
If unstable or unsuitable, just use trophic feeds
We want to minimize the use of NPO but if selected, need
to reassess next day
The PEP uPProtocol
Note, there are only a few absolute
contraindications to EN
Note indications for trophic feeds
Single centre pilot study Heyland DK, et al. Crit Care 2010. 2010;14(2):R78
PEP UP Protocol: other components Gastric residual volume threshold 300 mls or more (REGANE
Study 500 ml vs 250 mls safe Montejo et al 2010 Int Care Med)
Protein supplement Beneprotein® 14 grams mixed in 120 mls sterile water administered BID via NG until full EN
Motility agents are started immediately, rather than started when there is a problem– Maxeran® 10 mg IV q 6h (halved in renal failure)– Reassess need for motility agents daily– If still develops high gastric residuals, add erythromycin 200 mg q 12h– Can be used together for up to 7 days but should be discontinued when not
needed any more– Reassess need for motility agents daily
24 Hour Volume-based goal vs Hourly rate• Make up for missed hours over
the remaining hours• Max 150 ml/hr• RN latitude to adjust
A Change to Nursing Report
Adequacy of nutrition support =
24 hour volume of EN receivedVolume prescribed to meet caloric
requirements in 24 hours
Please report this % on
rounds as part of the GI
systems report
Efficacy of Enhanced Protein-Energy Provision via the Enteral Route in
Critically Ill Patients: The PEP uP Protocol
Daren K. HeylandProfessor of MedicineQueen’s UniversityKingston General HospitalKingston, Ontario
A multi-center cluster randomized trial
Research QuestionsWhat is the effect of the new innovative feeding protocol, (PEP
uP protocol), combined with a nursing educational intervention on EN intake compared to usual care?
What is the safety, feasibility and acceptability of the new PEP uP protocol?
Hypothesis: this aggressive feeding protocol combined with a nurse-directed nutrition educational intervention will be safe, acceptable, and effectively increase protein and energy delivery to critically ill patients.
Design
Protocol utilized in all patient mechanically intubated within the first 6 hours after ICU admission
Focus on those who remained mechanically ventilated > 72 hours
18 sites(low performing
from survey)
Control
Intervention
Baseline Follow-up6-9 months later
Bedside Written Materials DescriptionEN initiation orders Physician standardized order sheet for starting EN.
Gastric feeding flow chart Flow diagram illustrating the procedure for management of gastric residual volumes.
Volume-based feeding schedule Table for determining goal rates of EN based on the 24 hour goal volume.
Daily monitoring checklist Excel spreadsheet used to monitor the progress of EN.
Materials to Increase Knowledge and Awareness
Study information sheetsInformation about the study rationale and guidelines for implementation of the PEP uP protocol. Three versions of the sheets were developed targeted at nurses, physicians, and patients’ family, respectively.
PowerPoint presentationsInformation about the study rationale and how to implement the PEP uP protocol. A long (30-40 minute) and short (10-15 minute) version were available.
Self-learning module Information about the PEP uP protocol and case example to work through independently.
Posters A variety of posters were available to hang in the ICU during the study.Frequently Asked Questions (FAQ) document Document addresses common questions about the PEP uP Protocol.
Electronic reminder messages Animated reminder messages about key elements of the PEP uP protocol to be displayed on a monitor in the ICU.
Monthly newsletters Monthly circular with updates about the study.
Tools to Operationalize the PEP uP Protocol
Analysis
3 overall analyses:
– ITT* involving all patients (n = 1,059)
– Efficacy analysis involving only those that remain mechanically ventilated for > 72 hours and receive the PEP uP protocol (n = 581)
– Those initiated on volume-based feeds (n = 57)
* ITT: intention to treat
Flow of Clusters (ICUs) and Patients
Through the Trial
45 ICUs with < 50% nutritional intake in 2009 International Nutrition Survey assessed for eligibility
18 Randomized
9 assigned to intervention group 9 assigned to control group
522 patients met eligibility requirements and were enrolled
and included in ITT analysis.
537 patients met eligibility requirements and were enrolled and included in ITT analysis.
306 patients included in efficacy analysis
231 on MV ≤ 72 hours 197 on MV ≤ 72 hours
54 did not receive the PEP uP protocol
271 patients included in efficacy analysis
57 patients initiated on 24 hour volume feeds
Participating Sites Intervention (n = 9) Control (n = 9) p-valuesHospital type
Teaching Non-teaching
4 (44.4%)5 (55.6%)
4 (44.4%)5 (55.6%)
1.00
Size of hospital (beds) Mean (range) 396.9 (139.0, 720.0) 448.7 (99.0, 1000.0) 0.97
ICU structure Open
Closed 3 (33.3%)6 (66.7%)
4 (44.4%)5 (55.6%)
1.00
Case type Medical
Neurological Surgical
Neurosurgical Trauma
Cardiac surgery Burns Other
9 (40.9%)3 (13.6%)5 (22.7%)2 (9.1%)1 (4.5%)0 (0.0%)1 (4.5%)1 (4.5%)
9 (36.0%)2 (8.0%)
8 (32.0%)2 (8.0%)2 (8.0%)1 (4.0%)1 (4.0%)0 (0.0%)
0.97
Size of ICU (beds) Mean (range) 12.6 (7.0, 20.0) 16.3 (8.0,25.0) 0.12
Full time equivalent dietician (per 10 beds)
Mean (range) 0.5 (0.3, 0.9) 0.4 (0.0, 0.6) 0.76
Regions Canada
USA4 (44.4%)5 (55.6%)
5 (55.6%)4 (44.4%)
1.00
Intervention Control Baseline Follow-up Baseline Follow-up p-value
n 270 252 270 267Age
Mean ± SD 65.1 ± 15.5 64.1 ± 16.7 63.4 ± 15.1 61.4 ± 16.2 0.45Sex
Male (%) 157 (58.1%) 137 (54.4%) 170 (63.0%) 173 (64.8%)0.56
Admission category Medical
Elective surgery Emergent surgery
230 (85.2%)
14 (5.2%)26 (9.6%)
222 (88.1%)12 (4.8%)18 (7.1%)
213 (78.9%)23 (8.5%)
34 (12.6%)
212 (79.4%)23 (8.6%)30 (11.2%)
0.24
Admission diagnosis Cardiovascular/vascular
Respiratory Gastrointestinal
Neurologic Sepsis
Trauma Metabolic
Hematologic Other non-operative conditions
Renal-operative Gynecologic-operative
Orthopedic-operative Other operative conditions
40 (14.8%)110 (40.7%)35 (13.0%)19 (7.0%)37 (13.7%)
0 (0.0%)11 (4.1%)1 (0.4%)7 (2.6%)2 (0.7%)1 (0.4%)1 (0.4%)6 (2.2%)
43 (17.1%)112 (44.4%)19 (7.5%)19 (7.5%)20 (7.9%)2 (0.8%)15 (6.0%)0 (0.0%)15 (6.0%)0 (0.0%)0 (0.0%)1 (0.4%)6 (2.4%)
31 (11.5%)78 (28.9%) 29 (10.7%) 30 (11.1%) 57 (21.1%)17 (6.3%)13 (4.8%)0 (0.0%)5 (1.9%)0 (0.0%)0 (0.0%)1 (0.4%)9 (3.3%)
51 (19.1%)81 (30.3%)29 (10.9%)28 (10.5%)25 (9.4%)18 (6.7%)6 ( 2.2%)1 (0.4%)7 (2.6%)3 (1.1%)1 (0.4%)3 (1.1%)
12 (4.5%)
undefined
APACHE II score Mean ± SD 23.0 ± 7.2 23.5 ± 7.1 21.1 ± 7.3 21.1 ± 7.3 0.53
Patient Characteristics
(n = 1,059)
Patient Nutrition Assessment Information (All patients – n = 1,059)
Intervention Control Baseline Follow-up Baseline Follow-up p-value
n 270 252 270 267Height
Mean ± SD 1.7 ± 0.1 1.7 ± 0.1 1.7 ± 0.2 1.7 ± 0.1 0.55
Weight Mean ± SD 81.0 ± 25.3 81.4 ± 26.3 83.5 ± 26.5 83.7 ± 22.6 0.77
Body mass index (kg|m2)Mean ± SD 28.6 ± 8.2 28.6 ± 9.6 29.1 ± 8.1 28.6 ± 7.0 0.96
Prescribed energy intake (kcals)Mean ± SD 1,776.6 ± 352.4 1,774.8 ± 339.3 1,768.6 ± 412.1 1,784.4 ± 387.9 0.82
Prescribed protein intake (g)Mean ± SD 86.0±22.2 86.0 ± 19.8 99.9 ± 29.6 100.1 ± 27.8 0.09
Prescribed energy intake by weight (kcals|kg)
Mean ± SD 23.3 ± 5.9 23.2 ± 5.9 22.1 ± 4.9 22.3 ± 5.5 0.79
Prescribed protein intake by weight (g|kg)
Mean ± SD 1.1 ± 0.3 1.1 ± 0.3 1.2 ± 0.3 1.2 ± 0.3 0.26
Clinical Outcomes (All patients – n = 1,059)
Intervention Controlp-value
Baseline Follow-up Baseline Follow-upLength of ICU stay (days)*
Median (IQR†)
6.1 (3.4,11.1)
7.2 (3.4,11.1)
6.4 (3.3,12.6)
5.7 (2.8,11.8) 0.35
Length of hospital stay (days)*
Median (IQR)
14.2 (8.1,29.8)
13.5 (8.1,28.4)
16.7 (7.5,27.7)
13.8 (7.1,26.6) 0.73
Length of mechanical ventilation (days)*
Median (IQR)
3.7 (1.6,9.1)
4.3 (1.3,9.9)
3.1 (1.4,8.4)
3 (1.4,7.3) 0.57
Patient died within 60 days of ICU admission
Yes 70 (25.9%)
68 (27.0%)
65 (24.1%)
63 (23.6%) 0.53
* Based on 60-day survivors only. Time before ICU admission is not counted.
† IQR: interquartile range
Change of Nutritional Intake from Baseline to Follow-up of All the Study Sites (All patients)
% Calories Received/Prescribed
% c
alor
ies
rece
ived
/pre
scrib
ed
326326
326326
331331
331331
360360
360360
371371
371371
372372372372
373373373373
374374
374374
375375
375375390390
390390
Baseline Follow-up
2030
4050
6070
80
p value <0.0001
Intervention sites
% c
alor
ies
rece
ived
/pre
scrib
ed
p value=0.65
327327 327327
p value=0.65p value=0.65
359359
359359
p value=0.65p value=0.65
362362
362362
p value=0.65p value=0.65p value=0.65p value=0.65p value=0.65p value=0.65
376376
376376
p value=0.65
377377
377377
p value=0.65
378378378378
p value=0.65
379379
379379
p value=0.65
380380
380380
p value=0.65p value=0.65
404404
404404
p value=0.65p value=0.65
Baseline Follow-up
2030
4050
6070
80
Control sites
p value = 0.001 p value = 0.71
% p
rote
in re
ceiv
ed/p
resc
ribed
326326
326326
331331
331331
360360
360360
371371
371371
372372
372372
373373 373373
374374
374374
375375
375375390390
390390
Baseline Follow-up
2030
4050
6070
80
p value <0.0001
Intervention sites
% p
rote
in re
ceiv
ed/p
resc
ribed
p value=0.78
327327 327327
p value=0.78p value=0.78
359359
359359
p value=0.78p value=0.78
362362 362362
p value=0.78p value=0.78p value=0.78p value=0.78p value=0.78p value=0.78
376376
376376
p value=0.78
377377377377
p value=0.78
378378
378378
p value=0.78
379379
379379
p value=0.78
380380
380380
p value=0.78p value=0.78
404404
404404
p value=0.78p value=0.78
Baseline Follow-up
2030
4050
6070
80
Control sites
% Protein Received/Prescribed
Change of Nutritional Intake from Baseline to Follow-up of All the Study Sites (All patients)
p value = 0.005 p value = 0.81
ICU Day
% c
alor
ies
rece
ived
/pre
scrib
ed
1 2 3 4 5 6 7 8 9 10 12
010
2030
4050
6070
8090
100
n ITTn Eff icacyn FVF
24311357
21911357
19411357
17110854
15310552
1389646
1188340
1077535
835926
765223
594017
523514
ITTEfficacyFull volume feeds
ICU Day
% p
rote
in re
ceiv
ed/p
resc
ribed
1 2 3 4 5 6 7 8 9 10 120
1020
3040
5060
7080
9010
0
n ITTn Efficacyn FVF
24311357
21911357
19411357
17110854
15310552
1389646
1188340
1077535
835926
765223
594017
523514
ITTEfficacyFull volume feeds
Daily Proportion of Prescription Received by EN in ITT,Efficacy and Full Volume Feeds Subgroups
(Among Patients in the Intervention Follow-up Phase)
Compliance with PEP uP Protocol Components (All patients n = 1,059)
0102030405060708090
100
SupplementalProtein (ever)
SupplementalProtein
(first 48hrs)
Motility Agents(ever)
Motility Agents(first 48hrs)
Peptamen 1.5
Intervention - Baseline Intervention - Follow-upControl - Baseline Control - Follow-up
Perc
ent
Difference in Intervention baseline vs. follow up and vs. control all <0.05
-1
1
3
5
7
9
11
13
15
Vomiting Regurgitation Macro Aspiration Pneumonia
Intervention - Baseline Intervention - Follow-up
Control - Baseline Control - Follow-up
Complications (All patients – n = 1,059)
p > 0.05
Perc
ent
Vomiting Regurgitation Macro Aspiration Pneumonia
Nurses’ Ratings of Acceptability
After GroupMean (Range)
24 hour volume based target 8.0 (1-10)Starting at a high hourly rate 6.0 (1-10)Starting motility agents right away 8.0 (1-10)Starting protein supplements right away 9.0 (1-10)Acceptability of the overall protocol 8.0 (1-10)
1 = totally unacceptable and 10 = totally acceptable
Overall, how acceptable is this new PEP uP feeding protocol to you?
Need more instructions to include all staff members Too much confusion over what protocol was supposed to be
May need a few adjustments however I think its overall acceptable
Good if everyone knows how to do it Initial starting dose is too high Maybe we needed more awareness by the MDs
Barriers to ImplementationDifficulties embed into EMR*Non-comprehensive dissemination
of educational tools
Involvement of nurse educator (nurses owned it)
Ongoing bedside encouragement and coaching by site dietitian
* EMR: electronic medical records
Facilitators to Implementation
PEP uP Trial ConclusionStatistically significant improvements in
nutritional intake – Suboptimal effect related to suboptimal implementation
Safe
Acceptable
Merits further use
Can successfully be implemented in a broad range of ICUs in North America
Learning from the Trial : Next Steps
Change PEP uP protocol first day order to simplify (25 ml/hr for day 1)
Improve documentation of protein supplements (add to MAR!)
Develop PEP uP collaborative (community of practice)– PEP uP demonstration sites– Revise and disseminate tools
Audit practice again in early 2013
Call to action – is there room and interest to improve feeding practice in your ICU?
Identify nutrition champions – RNs, MDs, RDs
Feeding successfully requires a team approach
Education– Comprehensive education of the entire ICU team is essential – Tools and resources are available at criticalcarenutrition.com
Ongoing monitoring/feedback
Introduce PEP uP in YOUR ICU!
Education and Awareness Tools
PEP uP Pocket Guide PEP uP Poster
Protocol to Manage Interruptions to EN Due to Non-GI Reasons
Can be downloaded from www.criticalcarenutrition.com
PEP uP Monitoring Tool
Prompts for high risk patients improving calorie and protein intakes (≥ 80%
prescribed) starting motility agents, small bowel feeding, supplemental PN
Thanks Questions?