Protocol summary

Summary
Our aim is to compare the effects of Arginine and Citrulline supplementation on the prognosis of critically ill patinents in intensive care unit receiving enteral nutrition,A total of 105 critically traumatic patients admitted to the intensive care units and receive entral nutritional support will be recruited and randomly allocated into three groups. patients are head trauma patients graid 2,3.Two groups will be intervened each by citrulline or arginine (10 gam/day for 10 days) and the third group will revived just enteral nutritional support without immune supplements. pateints are between 20 -70 years old, with BMI:18.5-30, and eligible of enteral nutrition support.Septic, Hemodynamically and metabolically unstable patients, and more than 3 days NPO will be excluded from the study.This clinical trial will be executed in 5 trauma ICUs at a trauma center in teaching hospital of Kamyab in Mashhad, Three groups will be compared for clinical severity (evaluaes with APACHI II score), length of hospital stay and complications, inflammatory state (CRP,IL6) nutritional markers (RBP, Pre-Albumine), lipide profile (LDL-C, HDL-C, Cholestrol, Triglycirid), plasma glucose, electrolytes, liver enzymes levels(AST, ALT, ALP, LDH total), NO production, PAB( Pro-oxidant and Anti oxidant Balance), urea and creatinine. Serum levels of Arginine, Citrulline, Ornithine, Glutamine and lysine.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108027199N1
Registration date: 2011-10-28, 1390/08/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-10-28, 1390/08/06
Registrant information
Name
Bahareh Barkhidarian
Name of organization / entity
Mashad univesity of medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 1844 5309
Email address
barkhib881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashad university of medical sciences and P.N.C food supplement company
Expected recruitment start date
2011-09-29, 1390/07/07
Expected recruitment end date
2011-12-28, 1390/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Arginine and Citrulline supplementation on the prognosis of critically ill patinents in intensive care unit receiving enteral nutrition
Public title
Comparison of Arginine and Citrulline
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: AGE:20-70 years old ;BMI:18.5-30 Exclusion criteria: hemodynamically and metabolically unstable patients; more than 3 days NPO; any condition that we can not use enteral feeding
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashad university of medical sciences
Street address
Sakhteman ghoreishi, Daneshgah street
City
Mashad
Postal code
91375345
Approval date
2011-01-15, 1389/10/25
Ethics committee reference number
89479

Health conditions studied

1

Description of health condition studied
head trauma patients
ICD-10 code
S06
ICD-10 code description
Intracranial injury

Primary outcomes

1

Description
death
Timepoint
28 days follow up
Method of measurement
daily assessment

2

Description
body mass index
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on BMI equation

3

Description
ventilator depending
Timepoint
during hospital stay
Method of measurement
daily assessment

4

Description
lenght of hospital stay
Timepoint
in day of release
Method of measurement
based on date of admission and release

5

Description
ALT
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

6

Description
AST
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

7

Description
SEVIERITY OF ILLNESS
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
APACHEII

8

Description
LDH
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

9

Description
ALP
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

10

Description
FBS
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

11

Description
BUN
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

12

Description
CREATININE
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

13

Description
CHOLESTROL
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

14

Description
LDL
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

15

Description
HDL
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

16

Description
TG
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

17

Description
BILLIRUBIN TOTAL
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

18

Description
DIRECT BILLIRUBINE
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

19

Description
Na
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

20

Description
potassium
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

21

Description
total calcium
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

22

Description
magnesium
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

23

Description
phpsphor
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

24

Description
albumine
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

25

Description
total protein
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

26

Description
nitric oxide
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

27

Description
pro oxidant _ anti oxidant balance
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

28

Description
pre albumine
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

29

Description
CRP
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

30

Description
IL6
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

31

Description
SERUM AMINO ACIDS(ARGININE, GLUTAMINE, CITRULLINE, LYSINE, ORNITHINE)
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

32

Description
weight
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

33

Description
Mid Arm Circumferences
Timepoint
day 0 and day 11 (first and last days of intervention)
Method of measurement
based on labratory measurement

Secondary outcomes

1

Description
side effect
Timepoint
during intervention
Method of measurement
daily assessment

Intervention groups

1

Description
Arginine group recieves 10 g/day arginine powder in 2 seprate 5 gram doses
Category
Treatment - Other

2

Description
Citrulline group recieves 10 g/day citrulline powder in 2 seprated 5 gram doses
Category
Other

3

Description
control group will not recieves any supplement
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
shahid kamyab hospital
Full name of responsible person
Street address
City
mashad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashad university of medical sciences
Full name of responsible person
Mashad university of medical sciences
Street address
Sakhteman Ghoreishi, Daneshgah street, Mashad
City
Mashad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashad university of medical sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Karen nutrilife co
Full name of responsible person
Ali Mazidi
Street address
number2, Atefi street, Afrigha blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karen nutrilife co
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashad university of medical sciences
Full name of responsible person
Bahareh Barkhidarian
Position
MSC
Other areas of specialty/work
Street address
Paradise Daneshgah
City
Mashad
Postal code
91779-48564
Phone
+98 51 1844 5309
Fax
Email
BARKHIB881@MUMS.AC.IR
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashad university of medical sciences
Full name of responsible person
Mohammad Safarian
Position
MD, MSc,PhD
Other areas of specialty/work
Street address
Paradise Daneshgah
City
Mashad
Postal code
91779-48564
Phone
+98 51 1800 2359
Fax
+98 51 1882 8574
Email
safarianm@mums.ac.ir ms11@alumni.soton.ac.uk
Web page address
WWW.MUMS.AC.IR

Person responsible for updating data

Contact
Name of organization / entity
Mashad university of medical sciences
Full name of responsible person
Bahareh Barkhidarian
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 51 1800 2359
Fax
Email
BARKHIB881@MUMS.AC.IR
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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