Efficacy of enteral nutrition with commercial formula and Taurine Supplementation on Clinical outcome and nutritional status of Critically ill burned patients in burned intensive care unit
The aim of this study is to evaluate the effect of Taurine supplement and different enteral nutrition type ( commercial or blenderized) on the inflammatory factors and clinical outcome of critically ill burned patients with systemic inflammatory response syndrome in intensive care unit. A single blinded, clinically randomized controlled trial is designed on 45 ICU patients aged between 18 - 85 years old. These patients are divided into three groups of 15, with enteral nutrition initiated in the first 6-24 hours of injury. Patients with TBSA of burn>20% and enteral nutrition requirement of at least 48 hours, without renal or hepatic failure. First group is given enteral hospital nutrition (control group), the second group receives commercial standard formula nutrition, while the third group receives enteral commercial standard formula and 50mg/kg/bw taurine supplement. Energy requirement is calculated by Harris Benedict equation. Duration of intervention is 10 day. Primary outcome is assessed by SOFA score pattern change by measuring organ dysfunction evaluation. The secondary outcome is assessed by any alteration in immune system and nutritional status, measuring plasma taurine level, IL-10, TNF- alpha, hs-CRP and prealbumin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307082017N13
Registration date:2014-03-17, 1392/12/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-17, 1392/12/26
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center of Infectious and Tropical Diseases
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of enteral nutrition with commercial formula and Taurine Supplementation on Clinical outcome and nutritional status of Critically ill burned patients in burned intensive care unit
Public title
Efficacy of enteral nutrition with commercial formula and Taurine Supplementation on Clinical outcome and nutritional status of Critically Ill burned patients in burned intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Burned patients between the age18 and 85 years with total body surface area of burn more 20%; enteral feeding requirement of at least 48 h and expected length of >48h stay in the ICU; patients without hepatic failure; renal failure; inborn errors of amino-acid metabolism; metabolic acidosis(pH less7.35); absolute contraindication to enteral nutrition; non pregnant woman.
Exclusion criteria:
patients who died before the end of intervention; patients unable to tolerate enteral feeding.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht street, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2013-01-20, 1391/11/01
Ethics committee reference number
91187
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T30-2, T30
ICD-10 code description
Burn of second degree, body region unspecified, Burn of third degree, body region unspecified
Primary outcomes
1
Description
Clinical outcome measurement
Timepoint
day 1,3,6,9
Method of measurement
Sequential Organ Failure Assessment(SOFA) score
Secondary outcomes
1
Description
Effect on Immune System
Timepoint
Baseline and end of intervention
Method of measurement
TNF-alpha(ELISA test), Interleukin 10(IL-10)(ELISA test), High sensitivity C reactive protein( hs-CRP)(ELISA test)
2
Description
Effect on Nutritional Status
Timepoint
Baseline and end of intervention
Method of measurement
Prealbumin (Immunoturbidometric assay)
Intervention groups
1
Description
Hospital routine Nutrition
(Control Group)
Category
N/A
2
Description
(Intervention Group1) energy requirement is calculated by harris benedict equation, enteral nutrition starts with 25ml/h enteral standard formula and increases to goal. Duration of intervention is ten days.
Category
Treatment - Other
3
Description
Intervention Group 2: energy requirement is calculated by harris benedict equation, enteral nutrition starts with 25ml/h standard enteral formula and increases to goal. 50 mg/kg BW.day of Taurine is given to patients. Duration of intervention is ten days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Alireza Ostadrahimi
Street address
Azadi Street, Sina Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Center of Infectious and Tropical Diseases, Tabriz University of Medical Sciences
Full name of responsible person
Dr Behrouz Naghili
Street address
Azadi Street, Sina Hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center of Infectious and Tropical Diseases, Tabriz University of Medical Sciences
Proportion provided by this source
100
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
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Sima lak
Position
Ph.D Student of Nutrition
Other areas of specialty/work
Street address
Golgasht Street, Attar Neyshaboori Avenue, Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
lak_sima@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition,Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Ostadrahimi
Position
Ph.D of Nutrition Sciences
Other areas of specialty/work
Street address
Golgasht ُStreet, Attar Neishaboori Avenue, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
ostadrahimi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Sima lak
Position
Ph.D Student of Nutrition
Other areas of specialty/work
Street address
Golgasht street, Attar Neishaboori Avenue, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)