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EAT ICU Trial
1. EAT-ICU TRIAL
D e p a r t m e n t o f I n t e n s i v e c a r e ,
C o p e n h a g e n U n i v e r s i t y H o s p i t a l ,
R i g s h o s p i t a l e t , C o p e n h a g e n , D e n m a r k
Journal Club
Sabahat Zaidi
Senior Clinical Fellow
NUH
2. Background. The need.
Critical illness leaves patients with nutritional deficit, muscle weakness,
anorexia, global muscle loss.
ICU Acquired Weakness (ICU-AW). Critical care myopathy. Critical Care
polyneuropathy.
Nutrition in critically ill is good.
How much to feed?
How to calculate the requirements? Individualistic vs. generalist
When to start EN vs. PN? Early vs. late? ESPEN (early parenteral) vs. ASPEN
(late parenteral)
3. The Question!
In critically ill patients, does Early Goal Directed Nutrition (EGDN) during
ICU stay compared to standard care nutrition delivery result in improved
physical quality of life at 6 months?
4. Design of the trial
Single center study,
Randomized control trial, (1:1) two computer-generated randomization lists
with random block size.
Blinded Outcome Assessment.
Allocation were concealed in envelopes in accordance with SNOSE principle.
Intervention commenced within 24 hours.
200 pts. were required to demonstrate a 15% relative reduction in physical
component summary (PCS) score at 6 months with a significance level 0.05
and 80% power.
5. Population
Inclusion Criteria: 18 years of age or older within 24 h of any ICU admission
for inclusion if they were
acutely admitted to the ICU;
had an expected length of stay in the ICU of more than 3 days;
were mechanically ventilated via a cuffed endotracheal or tracheotomy tube;
had a central venous catheter and
were expected to read and understand Danish.
8. Intervention
Early Goal Directed Nutrition Arm
Calculated nutrition requirements:
Energy delivery directed by indirect calorimetry (IC) at randomization and every other day 24-h
urinary urea excretion (nitrogen use) was assessed daily and converted to metabolic protein
consumption using Bistrian’s equation.
Nutrition provision was titrated to IC and nitrogen balance with the aim to meet 100% of energy and
protein needs on the first full trial day and for the duration of ICU stay (to a maximum of 90 days).
Protein was provided as at least 1.5 g/kg/day at all times during admission, regardless of urea
excretion.
Enteral nutrition was initiated within 24 h of randomization and supplemented with PN if necessary
to reach goal requirements.
In case of sustained hyperglycemia (defined as insulin requirement of at least 5 IU/h for > 12
consecutive hours), glucose was reduced and at a plasma urea above 20 mmol/l, protein was reduced
by 0.2 g/kg/day
Supplemental PN was used if energy and protein needs could not be met by EN alone.
9. Control
Standard Care
Energy requirements calculated by 25 kcal/kg/day
EN commenced within 24 hours of randomization and gradually increase as tolerated.
If on day 7 energy needs were not met, supplemental PN was provided.
10. Outcome
Primary outcome:
Physical quality of life after 6 months based on PCS score (Mean PCS score 22.9 vs. standard care: 23.0; p
= 0.99) did not differ between the two groups.
Secondary outcomes:
Mortality at day 28, day 90 and at 6 months: no statistical difference between groups
Day 28: 20% dead in EGDT vs. 21% in control group
Day 90: 30% dead in EGDT vs. 32% in control group
6 months: 37% dead in EGDT vs. 34% in control group
Cumulative energy and protein balances at day 1, 3 and 7 and over the course of the ICU stay was higher
in the EGDN group.
Insulin requirement: the EGDN group received a greater median (IQR) dose of insulin and had a
greater proportion of BGL ≥ 15 mmol/L,
Episodes of hyperglycemia: More patients in the EGDN group experienced at least one episode of
hyperglycemia
No difference in: length of stay among survivors in ICU or hospital, new organ failure, time to any
infection or type of nosocomial infection, rates of hypoglycemia.
11. Authors Conclusion
The EGDN strategy resulted in greater energy and protein delivery in the ICU
compared to standard care, but no differences were observed in PSC score at 6
months or any other clinically important outcomes.
12. Strengths
A highly relevant clinical question especially when previous evidences are
unequivocal.
Randomized, blinded outcome assessment.
The primary outcome was physically focused outcome as compared to muscle
functionality.
Study design attempts to titrated nutrition based on metabolic changes
that occur during critical illness. Measured energy expenditure.
Provides further evidence about the utility of IC in critical illness.
Strictly followed the ESPEN guidelines.
13. Limitations
Single center study, and so the results may not be generalizable to all
populations.
The primary outcome was a long term outcome, but the intervention was early
and very short duration. It may not be biologically plausible that the
intervention would effect the outcome.
Missing data was imputed. It seemed to be well understood and conducted by
the authors but there is always a risk of inappropriate imputation.
The patients may not have been likely to benefit from intervention as they were
not long stay patients (7 days).
Early nutrition intervention when metabolic processes are aimed to mobilize
endogenous energy stores may place the patient under further metabolic stress
14. My take!
Doesn’t change practice. Probably will delay PN feeding in critically ill patient
as no outcome benefit. High glucose production initially, may lead to
overfeeding.
Septic patients 47% hasn’t shown any benefit per say. Need more info on non-
septic patients.
Calories were administered as per actually energy expenditure. IC.
Significantly low HRQOL score. Low skeletal muscle functional scores, mass scores.
Less gut translocation, Meets the catabolic demands of the body, supports the immune response to illness.
A cookie or Grand Big Macburger. Overfeeding risks hyperlipidemia, hyperglycemia, azotemia, fluid overload, CO2 production, liver damage.
21 RCT has supported early EN. However, anorexia is an evolutionary response to illness hence don’t feed early. Early PN in EPaNIC trial has not shown benefits!
Sequentially Numbered, Opaque Sealed Envelopes (SNOSE).
Estimates were based on previous study in ICU population.
Physical and mental comment summary is part of Short Form-12.
physical health problems (4 items), bodily pain (2 items), general health (5 items), vitality (4 items), social functioning (2 items)
Values are medians (interquartile ranges) or numbers (%). Additional baseline characteristics are presented in Table S1, ESM
BMI body mass index, ICU intensive care unit, SAPS Simplified Acute Physiology Score, SOFA Sequential Organ Failure Assessment
a BMI was calculated as estimated weight (kg) divided by height (cm) squared
b Patients were included within 24 h of admission to any ICU
c Stratification variable
d SAPS II was calculated from 17 variables. Scores range from 0 to 163 with higher scores indicating more severe disease
e SOFA score includes subscores ranging from 0 to 4 for each of 5 components (circulation, lungs, liver, kidneys and coagulation), aggregated scores ranging from 0 to
20 with higher scores indicating more severe organ failure. The scores were modified as cerebral failure was not assessed
Management common to both groups
The same EN and PN solutions
The same blood glucose level (BGL) aims (6-10 mmol/l)
Supplemental trace elements and vitamins based on measurements
The same gastric residual volume (GRV) cut off and protocol for management (based on usual practice in the ICU)
The same mobilization protocol (based on usual practice in the ICU)
Primary outcomes is highly variable in nutrition based trials in ICU.
Imputation is a process of replacing the data with substituted values.
On an average 7 days.