This randomized double blind clinical trial will be conducted for detecting the Influence of fat based versus glucose based enteral nutrition on serum glucose levels and clinical outcomes in hyperglycemic patients in ICU. 80 patients with age range in 18-65 years old, random blood sugar at 200mg/dl or above, with enteral feeding started in the first 24-48 hours after hospitalization and continued at least for 5 days, patients with lack of liver and kidney failure, nephrotic syndrome, hyperlipidemia, sepsis , infection and bed sores, no obesity; no history of taking part in other studies during the last 30 days will be included. Patients with taking glucose elevating agents (such as glucocorticoids and some cardiac agents...), expiration or discharge in 5 days after receiving first feeding will be excluded. Subjects will be divided into two groups. Control group will receive handmade enteral nutrition formula with macronutrient composition as protein; 20%: CHO; 50%; fat; 30% from total provided calorie. Intervention group will receive a formula with protein; 20%: CHO; 35%; fat; 45% from total provided calorie. Patients will receive formula through of NGT or PEG maximally for 15 consecutive days or until the end of ICU hospitalization.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100414901N7
Registration date:2015-11-04, 1394/08/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-11-04, 1394/08/13
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
Emam Khomeini Treatment and Educational Center
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2016-06-09, 1395/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fat based versus glucose based enteral nutrition on serum glucose levels and clinical outcomes in hyperglycemic patients in ICU
Public title
Fat based enteral nutrition for glucose control in ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Hospitalization in intensive care unit; Being over 18 and under 65 years old; Nasogasteric or PEG enteral feeding Started in the first 24-48 hours after hospitalization and continued at least for5 days; Random blood sugar at 200mg/dl or above; Lack of liver and kidney failure; Lack of Nephrotic syndrome; Lack of hyperlipidemia; Lack of sepsis , infection and bed sores; Lack of obesity; No history of taking part in other studies during the last 30 days;
Exclusion criteria: Expiration or discharge in 5 days after receiving first feeding; No taking glucose elevating agents( such as glucocorticoids and some Cardiac agents,..)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
1
Registry name
Clinicaltrials.gov
Secondary trial Id
Nct02584907
Registration date
2015-10-01, 1394/07/09
Ethics committees
1
Ethics committee
Name of ethics committee
International Branch of Shahid Beheshti University of Medical Sciences
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods
City
Tehran
Postal code
Approval date
2015-09-22, 1394/06/31
Ethics committee reference number
34199/د/1394
2
Ethics committee
Name of ethics committee
Urmia medical sciences university
Street address
Research and technology vice chancellor- djahad Ave-Resalat Bld-Urmia,iran
City
Urmia
Postal code
5714783734
Approval date
2015-10-28, 1394/08/06
Ethics committee reference number
IR.UMSU.REC.1394.261
Health conditions studied
1
Description of health condition studied
Hyperglycemia
ICD-10 code
R73.9
ICD-10 code description
Hyperglycaemia, unspecified
Primary outcomes
1
Description
Mean random Blood Sugar
Timepoint
Daily
Method of measurement
mg/dl with laboratory kit
Secondary outcomes
1
Description
Ventilator dependance time
Timepoint
Daily
Method of measurement
Counting the number of days with Ventilator dependance
2
Description
ICU stay duration
Timepoint
At the end of study
Method of measurement
Counting the number of days for ICU stay
3
Description
Infection
Timepoint
Daily
Method of measurement
Incidence or Lack of incidence based on laboratory results
4
Description
Bed sore
Timepoint
Daily
Method of measurement
Incidence or Lack of incidence with viewing
5
Description
Blood Lipid Profiles
Timepoint
Weekly
Method of measurement
Mg/dl with laboratory kit
Intervention groups
1
Description
Fat based EN with predefined specific fat percent
Category
Treatment - Other
2
Description
Carbohydrate based EN with predefined specific CHO percent
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Treatment and Educational Center
Full name of responsible person
Davoud Vahabzadeh
Street address
Ershad Aven, Moddares Bld, Urmia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Emam Khomeini Treatment and Educational Center
Full name of responsible person
Davoud vahabzadeh
Street address
Ershad Aven,Moddares Bld, Urmia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Emam Khomeini Treatment and Educational Center
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