Effect of enteral feeding composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit patients with acute respiratory failure
This study aimed to investigate the effect of enteral feeding’s macronutrient composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients with acute respiratory failure. In this double-blind randomized control trial, 42 patients of both sexes and diagnosed with acute respiratory failure in ICU that receive enteral feeding, will be randomly assigned to three groups of 14 each. First Intervention group; high-protein low-carbohydrate diet with high olive oil, the second intervention group; high-protein low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula. Intravenous levels of uric acid, hs-CRP, IL-6 and TAC measured at days 0 and 10. As well as, organ failure, duration of ventilation, length of ICU stay and mortality rates will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021614901N6
Registration date:2015-03-27, 1394/01/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-27, 1394/01/07
Registrant information
Name
Zahra Vahdat Shariatpanahi
Name of organization / entity
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7484
Email address
z.shariatpanahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of enteral feeding composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit patients with acute respiratory failure
Public title
Feeding composition and acute respiratory failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: enrolled in ICU; age older than 18 years old; need to be mechanically ventilation; have enteral feeding; no previous diabetes, HIV infection, nervous system, liver failure, nephrotic syndrome; not passed more than 48 hours from diagnose of acute respiratory failure
Exclusion criteria: death at less than three days of enteral feeding administration; extubation at less than three days of enteral feeding administiration
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Sciencees,
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods
City
Tehran
Postal code
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
054575
Health conditions studied
1
Description of health condition studied
Acute Respiratory Failure
ICD-10 code
J96.0
ICD-10 code description
Acute Respiratory Failure
Primary outcomes
1
Description
length of ventilation
Timepoint
daily
Method of measurement
observation
Secondary outcomes
1
Description
hs-CRP
Timepoint
day 0, day 10
Method of measurement
ELIZA
2
Description
TAC
Timepoint
day 0, day 10
Method of measurement
autoanalyzer
3
Description
uric acid
Timepoint
day 0, day 10
Method of measurement
ELIZA
4
Description
length of ICU stay
Timepoint
daily
Method of measurement
observation
5
Description
organ failure
Timepoint
daily
Method of measurement
clinical and paraclinical
6
Description
mortality
Timepoint
daily
Method of measurement
observation
Intervention groups
1
Description
Intervention 1: high-protein low carbohydrate diet with high olive oil
Category
Other
2
Description
Intervention 2: high-protein low carbohydrate diet with high sunflower oil
Category
Other
3
Description
Control: common high protein kitchen diet
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul Akram Hospital
Full name of responsible person
Dr Nader Tavakoli
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr Majid Hajifaraji
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Research Institute
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 and Food Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Vahdat Shariatpanahi
Position
MD, PhD in nutrition
Other areas of specialty/work
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods,