dietiti an manual - home - critical care nutrition · 2017-03-01 · ration ..... recruitment ted...
TRANSCRIPT
Version 1
1.2b: 09-Fe
A R
b-2016
Random
m
Die
This sIde
mizEd Tri
minimIZ
etitiIntended A
study is regisentification n
ial of EN
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an M
Audience: Di
stered at Clinnumber NCT
NtERal G
mal Injur
Manietitians
nicaltrials.goT00985205
Glutamin
ry
nual
ov.
1
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l
Version 1
Table oDocumen
Study Co
Glossary
Study Sy
Overvie
Study D
Setting
Study P
Study I
Outcom
Trial Du
Study
Estima
Diagram
Training .
Patient P
Inclusio
Exclusio
Investiga
Nutrest
Maltrin
Dosing
Duration
Standard
1) Pr
2) Pr
3) Vit
4) Sp
1.2b: 09-Fe
of Contennt History ...
ontacts ........
y ..................
ynopsis .......
ew ................
Design...........
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Population ....
ntervention .
mes ...............
uration .........
Recruitment
ated Total Stu
m of Study Ov
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Population ...
on Criteria ....
on Criteria ....
ational Produ
tore (L Glut
n® M100 Malt
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dization of N
escribed Ene
escribed Prot
tamin & Mine
pecialized nut
b-2016
nts ...................
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Period ..........
udy Duration .
verview ........
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uct ...............
tamine) .........
todextrin (con
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utrition Prac
rgy needs .....
tein needs ....
eral Prescript
tritional form
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Version 1
5) Op
6) Gl
Data Col
Nutritio
Daily N
Appendic
Append
Append
Append
Referenc
1.2b: 09-Fe
ptimization of
ycemic contr
lection ........
on Assessmen
utrition Rece
ces .............
dix A: Enteral
dix B: Nutritio
dix C: Daily Nu
ces ..............
b-2016
f the Delivery
ol .................
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nt/Timing (se
eived (see App
...................
Feeding Prot
on Assessmen
utrition Form
...................
y of Enteral N
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e Appendix B
pendix C) ......
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tocol .............
nt/Timing For
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Version 1
Docum
Version:Version 1Version 1Version 1
Study Name Dr. Dare
Maureen
IT Help D
All quest In the evInvestigaOperatio
1.2b: 09-Fe
ment Histo
: Date 1: 10 Dece1.1: 29 Janu1.2: 09 Feb
Contacts
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Study OverviewThe primenteral gWe asseacquired hospital l Study DeA large, msevere b Setting ApproximEurope. Study Po2700 aduage 18 –inhalationwe requi Study InPatients 4 hours, operationunit, wha OutcomePrimary o Seconda Tertiary o
1.2b: 09-Fe
Synopsis
w mary purpose
lutamine adert that glutam
blood strealength of sta
esign multicenter, urns random
mately 60 ter
opulation ult patients w
– 59 years wen injury, a mre a TBSA ≥
ntervention will receive or orally 3 –
n, or discharatever comes
es outcome:
ary outcome:
outcomes:
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s
e of this studministration mine adminim infections
ay, and impro
double-blindmly allocated
rtiary acute c
with deep 2nd
e require a Tminimum of 1≥ 10%.
glutamine o– 4 times a drge from the s first.
6-month m
: Time to dis
Health-relaIncidence Hospital mDuration oAcute careHospital le
dy is to deterto severely stration will
s from Gram ove the phys
d, pragmaticd to receive e
care burn ce
d and/or 3rd dTBSA (Total5 % TBSA i
r maltodextray, for a totaacute care
mortality
scharge aliv
ated quality of acquired
mortality of mechanicae unit lengthength of stay
rmine the ovburn injureddecrease 6 negative or
sical function
c, randomizeenteral gluta
entres in Can
degree burn Burn Surfacs acceptable
rin (placebo/al of 0.5 g/kgunit, or 3 mo
ve
of life with pbacteremia
al ventilation of stay
y
verall treatmed patients in month morta
rganisms, ren of survivin
ed controlledamine or pla
nada, the Un
ns requiring sce Area) ≥ 2e. For patien
/control) throg/day until 7onths after a
particular focdue to Gram
n
ent effect anacute care uality, decrea
educe acute g burn injure
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nited States,
skin grafting20%, or in thnts aged 60
ough their fe days after t
admission to
cus on physim negative o
6
nd safety of units (ACUs
ase hospital-care unit aned patients.
0 patients w
, Australia a
. For patiente presence years or old
eding tube etheir last gra the acute c
cal functionorganisms
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with
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ts of an
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Trial DurStudy Re4 years -study. EstimateWe antic 6 month 4 year re6 month
DiagramBelow is sections
1.2b: 09-Fe
ration ecruitment P- based on a
ed Total Studcipate the tot
Start-up perecruitment pefollow-up pe
m of Study Oa diagrammof the Study
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Period approximatel
dy Duration tal study dur
riod eriod eriod
Overview matic represey Procedures
y 1 patient p
ration to be 5
entation of ths Manual for
per site per m
5 years, brok
he RE-ENERr comprehen
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emonstrated
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7
d in the pilot
appropriate udy activities
s.
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Trainin Each meexperienresponsi Each Dietraining w
Patient Inclusio
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ng
ember of the ce to assumble for ensu
etitian must will be provid
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n Criteria Deep 2nd andThe presence
ssessment t
Patient meeta. Patienb. Patienc. Patien
on Criteria 72 hours fro
This refers tolock starts foas been an our unit.
Patients youn
n patients wireatinine >1hours if a 2
n patients wi80 mmol/L f4 hours (or 8
Patients with
iver cirrhosis
Pregnancy (uge by each s
Contra-indicaBeing NPO i
Patients with
b-2016
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ring that s/h
have documded by CERU
tion
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e of deep 2nthat must be
ts one of thnts 18 – 59 ynts 18 – 59 ynts > 60 yea
om admissioo admission torm the timeextended pe
nger than 18
ithout know71 mmol/L o4 hour perio
ith acute onfrom baselin80 ml/last 4
chronic ren
s -Child’s cla
urine/blood tesite as part o
ation for EN: s not consid
injuries from
ch team shoubility for the pe and the lo
mented trainU Staff and
rd degree bund degree ane made by th
e followingyears of ageyears of agers of age wit
on to Acute Cto your ACU
e of admissioeriod of time
8 years of ag
wn renal disor a urine ouod of observa
n chronic ree or pre-admhours) will b
nal failure o
ass C liver d
ests for pregof standard
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uld be qualifproper conducal staff are
ing on the Rconducted e
urns requirind/or deep 3he surgeon/p
3 criteria:e with TBSA e with TBSA th TBSA > 1
Care Unit (AU. If a patienton to your une at another f
ge
sease, renal utput of less ation is not a
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gnancy will bof ACU prac
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ing grafting3rd degree bphysician.
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dysfunctionthan 500 mlavailable).
(pre-dialysisatinine or a u
will be exclu
be done on actice)
perforation, ifor Enteral N
contact.
cation, traininal. The Site trained in G
ZE study. Stson or via we
g burns requirin
H inhalation
e of consent red from anoption would burn prior to
n defined as l/last 24 hou
s), an absoluurine output
uded.
all women of
intra-abdomNutrition).
8
ng and Investigator
GCP (GCP 4
tudy specificebinar.
ng grafting is
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other facility,be a patient
o admission
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ute increase of <500 ml/l
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InvestiThe activand cont NutrestoNutrestosyndromfunctionsconditionfrom endrequiremsignificanGlutamincatabolicamino ac Maltrin® The MALthen pacpharmac(GRAS) apracticesand suitamaltodexcommon
1.2b: 09-Fe
Patients who f the Site Inv
Note that an i
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s in regulations, glutaminedogenous gluments for glutntly from thene concentrac disease stacid.
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b-2016
are moribunvestigator orisolated DNR
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e subjectivitypatient.
another indzed academ
abstract of thwould like to
tamine suppo consistent an. If the patiscontinue th
y to maltode
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tamine) no acid (L GA. L Glutam
on of gastroine concentratutamate. Datamine durin
e role of and ations decreaates, and thu
odextrin (co0 maltodextnderson Pace, white carbman food ingprepared as nd/or enzym) mixed with
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dy sizes: BMlculated usiny involved in
dustry sponsmic studies whe study to tho co-enroll.
plement for >administratioient receivedhe glutamine
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will both be
al appearanc
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ng burns, catnutritional re
ase and tissus glutamine
ontrol) rin is produc
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mes. Patientsh water or oteral nutrition
ected to survdoctor in chafulfil this crite
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ored ICU intwill be approvhe project le
> 24 hours pon of glutamd random or e prior to ran
starch, corn,
supplied in pce and taste.
owder that isced normallyl growth, funained in the cal studies itabolic illnesequirementsue glutamine
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ced by Grainhe trial. Maltowders thatlevels cons
wder by partis will receiveher liquids. Mn and has no
vive the nextarge). eria.
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tervention stved. For acaeader to obta
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corn produc
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t 72 hours in
n dry weight.MI, err on the
tudy (co-enrademic RCTsain pre-appro
omization. e 24 hr periodoses of op
cts or glutam
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etary intake athe role of a
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9
n the judgem
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rollment in aTs, forward a
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a source calories p Dosing Study intrecordedwith the u Patients enterally
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The patieused for clinically interventAssociate
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1.2b: 09-Fe
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b-2016
al energy. Thet.
ill be dosed F. By dry wet recorded o
glutamine oID if po, for a
a BMI <35 we-burn dry we
a BMI >35 w) based on t
dy Weight (A+ [(p
ng weight sh. If the clinic
change in thejusted in accbe recorded
e the study g operation,mission, wh
efining the ect or preciseguidance, w
er discharge
n of Nutri
study patient
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o reduce thee RE-ENERG
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in accordaneight, we meon a prior cha
r maltodextra total of 0.5
will receive 0eight (actualwill receive 0the adjusted
ABW) = Ideapre-burn dry
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interventio or until acuatever com
end of study e. There maywe generallyed from the a
ition Prac
ts be fed in a
ns and increa challenginge effect of vaGIZE study,
trin used in t
ce with the pean prior to rart or obtain
rin through th5 g/kg/day.
0.5 g/kg/dayl or estimate0.5 g/kg/day body weigh
al Body Wey weight – I
be changed Ianges the weweight, the pth the patienF.
on from randute care unes first.
treatment phy be unique
y mean whenacute care un
ctices
accordance w
eased nutritiog task and varying nutritioit is importan
this study co
patient’s preresuscitationed from a fa
heir feeding
y of either glued). y of either gluht, as per ca
eight (IBW) IBW) x 0.25]
IF the clinicaeight used fo
pharmacy wilnt’s current d
domizationit discharge
hase by 7 dafeatures to s
n the patientnit or enterin
with the Sta
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ontains appr
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tube, every
utamine or m
utamine or plculation bel
based on a]
al team chanor drug dosinll be notifieddrug dosing
until 7 daye, or until 3
ays post lassome patient is over the ng in their re
ndardization
ments in burnutrition praces as confourdize, as mu
10
roximately 1
weight and ely consisteer.
4 hours
maltodextrin
placebo ow.
BMI of 25
nges the weing due to a and the stuweight.
ys post last 3 months aft
st successfulnts that makeacute phase
ehabilitation
n of Nutrition
rns patients,ctices acrossunding factoruch as possi
9
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Version 1
the prescto withhopatients. Based onparticipatall patienranges b
1) P
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1.2b: 09-Fe
cription of enolding feeds
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Prescribed Equation, or arescription o
Use pre-burnbesity, followse the formu
Adjusted
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According toi. ii.
re-burn dry atients, if yoyou do not
Adjusted
Vitamin & Mlood levels
• • • • • • • • • •
b-2016
nteral and pafor high gas
ure and prove are recomn the study.ow for most
Energy needa simple weiof less than 3
dry weight. w your standula below.
Body Weigh+
Protein need
o % burn suIf > 50% bIf < 50% b
weight* shoour standard have an obe
Body Weigh+
ineral Presc(if blood teVitamin C:Vitamin A: Vitamin D:Vitamin E: Zinc (not eCopper SuSelenium: MagnesiumFolate: 0-1Thiamin: 0
arenteral nutstric residual
iding for sommmending co
After reviewcurrent prac
ds are to beight-based fo30 kcal/kg.
For Obese dard practice
ht (ABW) = + [(pre-burn
ds are to be
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uld be used practice is t
esity adjustm
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trition, microvolumes an
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patients, if ye. If you do
Ideal Body n dry weight
e calculated
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when calcuto adjust for ment practice
Ideal Body n dry weight
ould be givene as part o/day U/day o serum leve
day 0-220 mg/damg/day
ograms/day/day y y
onutrient delnd use of mo
for current pith the followctices at all t
ntinue.
d using Indiron average,
your standanot have an
Weight (IBt – IBW) x 0
d using the
to 2.5g/kg*/y to 2 g/kg*/d
lating proteiobesity, follo
e, use the fo
Weight (IBt – IBW) x 0
en as followof routine p
els
y
ivery and protility agents
practices acwing nutritionthe participa
rect Calorimshould not l
rd practice is obesity adju
W) based o0.25]
following:
/day day
n needs. Foow your stan
ormula below
W) based o0.25]
ws or depenpractice) :
11
ractices relats in these
cross the nal practicesating sites, th
metry, a predead to a
s to adjust foustment pra
on a BMI of
or Obese ndard practicw.
on a BMI of
nding upon
ted
s for hese
ictive
or ctice,
25
ce.
25
Version 1
Earlyis a
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1.2b: 09-Fe
ly supplemeallowed 2. S
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These rangesThis mea
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ii. Glutami
• • • •
Form
OptimizationThe use of ennterruptions trategies to o
minimum of 4esidual volumcceptable), a
ndicated. Re
Ongoing monnsure that thf the study p
Glycemic coThe use of a
etween the ecommendeatrogenic hyp
To minimglutamine
b-2016
entation by Standard mu
es of vitaminsnd beyond w
s of vitaminsans that the cted from the
nutritional f
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ed in order topoglycemia
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high dose Iultivitamin/m
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formulas ar
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ments or formlutamine (15
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utamic acid
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Refere 1 Masters Jul-Aug;2 2 TanakaBurned Patient 2000;13
1.2b: 09-Fe
ences
B, Wood F. N9(4):561-71.
H, Matsuda T
s Using Asco35:326-331
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Nutrition supp
T, Miyaganta
orbic Acid Adm
port in burns--
ni Y, et al.Re
ministration. A
-is there cons
duction of Re
A Randomize
sistency in pra
esuscitation F
ed, Prospectiv
actice? J Burn
Fluid Volumes
ve Study. Arc
20
n Care Res. 2
s in Severely
ch Surg.
2008