dietiti an manual - home - critical care nutrition · 2017-03-01 · ration ..... recruitment ted...

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Version 1 1.2b: 09-Fe A R b-2016 Random m Die This s Ide mizEd Tri minimIZ etiti Intended A study is regis entification n ial of EN ZE Therm an M udience: Di stered at Clin number NCT NtERal G mal Injur Man ietitians nicaltrials.go T00985205 Glutamin ry nual ov. 1 ne to l

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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

ZE Therm

an M

Audience: Di

stered at Clinnumber NCT

NtERal G

mal Injur

Manietitians

nicaltrials.goT00985205

Glutamin

ry

nual

ov.

1

ne to

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...........

....................

Population ....

ntervention .

mes ...............

uration .........

Recruitment

ated Total Stu

m of Study Ov

...................

Population ...

on Criteria ....

on Criteria ....

ational Produ

tore (L Glut

n® M100 Malt

....................

..................

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

.....................

...................

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 .................

...................

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

m ....................

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utrition ........

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B) ...................

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Version 1

Docum

Version:Version 1Version 1Version 1

Study Name Dr. Dare

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All quest In the evInvestigaOperatio

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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 ≥

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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

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care burn ce

d and/or 3rd dTBSA (Total5 % TBSA i

r maltodextray, for a totaacute care

mortality

scharge aliv

ated quality of acquired

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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

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y

verall treatmed patients in month morta

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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.

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, 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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Version 1

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

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m of Study Oa diagrammof the Study

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Period approximatel

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y 1 patient p

ration to be 5

entation of ths Manual for

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Trainin Each meexperienresponsi Each Dietraining w

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ember of the ce to assumble for ensu

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ssessment t

Patient meeta. Patienb. Patienc. Patien

on Criteria 72 hours fro

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n patients wi80 mmol/L f4 hours (or 8

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Patients with

b-2016

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have documded by CERU

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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

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ass C liver d

ests for pregof standard

intestinal ocdered a cont

m high voltag

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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RE-ENERGIZeither in pers

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dysfunctionthan 500 mlavailable).

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will be exclu

be done on actice)

perforation, ifor Enteral N

contact.

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ZE study. Stson or via we

g burns requirin

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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

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8

ng and Investigator

GCP (GCP 4

tudy specificebinar.

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other facility,be a patient

o admission

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plement for >administratioient receivedhe glutamine

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supplied in pce and taste.

owder that isced normallyl growth, funained in the cal studies itabolic illnesequirementsue glutamine

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al energy. Thet.

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ng weight sh. If the clinic

change in thejusted in accbe recorded

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study patient

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ts be fed in a

ns and increa challenginge effect of vaGIZE study,

trin used in t

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this study co

patient’s preresuscitationed from a fa

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10

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Adjusted

Vitamin & Mlood levels

• • • • • • • • • •

b-2016

nteral and pafor high gas

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Body Weigh+

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ds are to be

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uld be used practice is t

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to 2.5g/kg*/y to 2 g/kg*/d

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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

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ly supplemeallowed 2. S

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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

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ndices

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x B: Nutritio

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Refere 1 Masters Jul-Aug;2 2 TanakaBurned Patient 2000;13

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2008