Compariative study of Biceps Muscle Diameter under Ultrasound Guide in ICU & its Relation with Protein intake as a Indicator of Nutrition & Muscle atrophy
to compare protein delivery and muscle loss among patients who received a high protein enteral feeding and standard care.
Design
This was a randomized, double-blind, controlled clinical trial conducted at general ICU of Imam Hossein Hospital. A total of 100 patients were included. A random number generator software was used to prepare the randomization list.
Settings and conduct
Eligible patients were randomized in a 1:1 ratio to receive either the intervention or standard care. The intervention group received EN using a high-protein formula with a target protein delivery of 1.5 g/kg per day. The control group received standard nutrition care protocol, which aims to provide 1.0 g/kg/day protein. A blinded investigator (T.Sorbi) undertook the outcome measurements.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Adult aged 18-65 years admitted to ICU
2. Stay in ICU for at least 72 hours
Exclusion criteria:
1. GCS less than 5
2. Unstable Arm fracture
3. Wound & infection of the arm
4. Upper extremity numbness
5. Upper extremity thrombosis
6. Musculoskeletal diseases
7. pregnancy
8. Liver disease
9. End-stage renal disease
Intervention groups
High-protein enteral nutrition group
Standard care group
Main outcome variables
Changes in Biceps muscle thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200124046242N1
Registration date:2020-08-16, 1399/05/26
Registration timing:registered_while_recruiting
Last update:2020-08-16, 1399/05/26
Update count:0
Registration date
2020-08-16, 1399/05/26
Registrant information
Name
Tahereh Sorbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2281 4083
Email address
t.sorbi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compariative study of Biceps Muscle Diameter under Ultrasound Guide in ICU & its Relation with Protein intake as a Indicator of Nutrition & Muscle atrophy
Public title
Evaluation of Nutritional Statue of Patient in ICU with sonography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult 18_65 years admitted to ICU
Stay in ICU for at least 72 hours
Exclusion criteria:
GCS less than 5
Untable Arm fracture
Wound & infection of arm
Upper extremity numbness
Upper extremity thrombosis
Musculoskeletal diseas
pregnancy
Liver disease
End stage renal disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization with a block size of four was used for group allocation. The list of random numbers were generated using Excel software.
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
Ethics committee of Shahid Beheshti University of Medical Sciences