Comparison of the incidence of hypoalbuminemia in two groups of patients fed with hospital enteral formulas and Entrameal in the ICU department
Design
Clinical trial with control group, with parallel groups, phase 3 on 80 patients who are divided into two groups without randomization.
Settings and conduct
This study will be conducted in the ICU department of Imam Khomeini Hospital in Ilam province on 80 patients. In this way, two groups of 40 people will be selected from among all trauma patients hospitalized in the ICU of Imam Khomeini Hospital. After obtaining permission, to remove the patient from NPO status and start enteral nutrition in the form of nasogastric tube or percutaneous endoscopic gastrostomy, 40 patient will be selected. The first group will enter the study with enteral formula feeding method and the second group will enter the study with entrameal powders. all patients will be fed with the same method which determined by their group during the entire hospitalization period. Due to the fact that people will be chosen based on selective approach, blinding is not performed.
Participants/Inclusion and exclusion criteria
All trauma patients hospitalized in the ICU department of Imam Khomeini Hospital in Ilam province, which are divided into two groups; One group under hospital feeding with Entrameal powders and another group under hospital enteral formula feeding. The inclusion criteria are: 1- Complete satisfaction of the patient or the patient's family and 2- The patient is in the age group of 18-75 years. The exclusion criteria are: 1- the patient's dissatisfaction with the continuation of his diet and 2- a history of liver disease, heart disease (especially heart failure) and kidney failure.
Intervention groups
entrameal powders
Main outcome variables
Serum albumin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240214061005N1
Registration date:2024-04-14, 1403/01/26
Registration timing:prospective
Last update:2024-04-14, 1403/01/26
Update count:0
Registration date
2024-04-14, 1403/01/26
Registrant information
Name
Parinaz Tahmasebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3333 3783
Email address
najafi-s@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-18, 1403/02/29
Expected recruitment end date
2024-08-19, 1403/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the incidence of hypoalbuminemia in two groups of patients fed by hospital enteral formula and entrameal in the ICU setting
Public title
hypoalbuminemia in patients fed by hospital enteral formula and entrameal
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Complete satisfaction of the patient and the patient's family
Age group 18-75 years
Exclusion criteria:
Dissatisfaction of the patient from continuing his feeding method
A history or suffering of liver disease
History or suffering heart disease, especially heart failure
History or suffering from kidney failure
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not 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
Ilam University of Medical Sciences
Street address
Bangejab- Campus of Ilam University of Medical Sciences
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2024-01-30, 1402/11/10
Ethics committee reference number
IR.MEDILAM.REC.1402.234
Health conditions studied
1
Description of health condition studied
Fracture due to Trauma
ICD-10 code
M84.3
ICD-10 code description
Stress fracture
Primary outcomes
1
Description
Serum albumin level
Timepoint
24 hours after the intervention
Method of measurement
Biochemistry test of blood
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: In the first intervention group, patients will be gavaged with entera meal powders that contain industrial formulas for nutrition. The amount of feeding depends on the doctor's order and the patient's tolerance, which is usually the same for patients. The second intervention group: In this group, patients will be gavaged with homemade hospital soup. This soup consists of 80 grams of rice, 250 grams of boneless chicken, 300 grams of probiotic yogurt, 60 grams of liquid oil, 130 grams of chopped vegetables, 240 cc of natural apple juice and 75 grams of carbohydrate powder. This soup is prepared for the patient for 24 hours, which is given to the patient in the amount of 250 cc every 3 hours .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Ilam
Full name of responsible person
Sohila Najafi
Street address
Banganjab, Ilam University of Medical Sciences campus
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
najafi-s@medilam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Abas Maleki
Street address
Banganjab, Ilam University of Medical Sciences campus
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
abbasmaleki_ilam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Soheila Najafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Banganjab, Ilam University of Medical Sciences campus
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
najafi-s@medilam.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Soheila Najafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Banganjab, Ilam University of Medical Sciences campus
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
najafi-s@medilam.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Soheila Najafi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Banganjab, Ilam University of Medical Sciences campus
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
najafi-s@medilam.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available